## Protocol Section
### Identification Module
**NCT ID:** NCT02467179

**Acronym:** Amigo-AFL

**Brief Title:** Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus

**Official Title:** Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus

#### Organization Study ID Info
**ID:** 150318
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Diego
### Status Module
#### Completion Date
**Date:** 2018-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-27

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-10-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-06-27

**Type:** ACTUAL

**Results First Submit Date:** 2019-05-13

**Results First Submit QC Date:** 2019-06-07

#### Start Date
**Date:** 2015-03

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2015-06-09
**Type:** ESTIMATED
**Study First Submit Date:** 2015-06-03
**Study First Submit QC Date:** 2015-06-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Catheter Robotics, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Diego

#### Responsible Party

**Investigator Affiliation:** University of California, San Diego

**Investigator Full Name:** Gregory Kent Feld

**Investigator Title:** Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of the CTI is standard treatment for patients with a history of atrial flutter, and those undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation are used in standard clinical practice at The University of California, San Diego (UCSD) for ablation.

**Detailed Description:** Dr. Gregory Feld, M.D. is conducting a research study to find out more about the effects of using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus) on catheter stability (stabilization of the catheter during the procedure in order to prevent movement and dislodgement) using a combination of contact force (a measurement of the force applied by the catheter tip against the tissue during the ablation procedure), location, and duration measurements during ablation of the atrial flutter circuit. Published studies have indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray exposure, and ablation procedure time. Measuring contact force has also been shown to improve both short-term and long-term procedure success. However, research on ablation of the CTI specifically, is limited. This is a randomized study comparing robotic catheter manipulation using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray) time.

The ablation procedure is standard of care, however, if patients chose to enroll in the study they will be randomized to one of two groups: either manual or robotic catheter manipulation. Throughout the procedure, research personnel will collect information from the procedure including measurements of contact force, catheter stability, procedure duration, and fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial fibrillation or left atrial flutter, this will be performed subsequently in a standard manner, and will not be considered part of the research. Ablation of the CTI generally takes 45-60 minutes regardless of the technique used for manipulation of the catheters.

The patient's participation in the study will only last one day, the length of study procedure. There is no follow up associated with this study. All subjects will received standard of care treatment following their ablation.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

- Atrial Flutter

**Keywords:**

- Arrhythmia

- cavo-tricuspid isthmus

- atrial fibrillation

- atrial fibrillation ablation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

**Intervention Names:**

- Device: Manual Catheter Manipulation

**Label:** Manual Catheter Manipulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

**Intervention Names:**

- Device: Amigo™ Robotic Catheter Manipulation

**Label:** Amigo™ Robotic Catheter Manipulation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Amigo™ Robotic Catheter Manipulation

**Description:** Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.

**Name:** Amigo™ Robotic Catheter Manipulation

**Other Names:**

- cavo-tricuspid isthmus ablation

- atrial flutter ablation

- arrhythmia

- radiofrequency catheter ablation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Manual Catheter Manipulation

**Description:** Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.

**Name:** Manual Catheter Manipulation

**Other Names:**

- cavo-tricuspid isthmus ablation

- atrial flutter ablation

- arrhythmia

- radiofrequency catheter ablation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System

**Measure:** Contact Force Through Measurement of Force-time Integral (FTI)

**Time Frame:** At time of the ablation procedure, which typically lasts 30-60 minutes

#### Secondary Outcomes

**Description:** Determine fluoroscopy time to reach CTI block.

**Measure:** Fluoroscopy Time Measurements

**Time Frame:** at time of ablation procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate clinical indications.
* Must be able and willing to provide written informed consent
* Must be at least 18 years old.

Exclusion Criteria:

* Patient's refusal to participate in the study
* Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
* Pregnancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** La Jolla

**Country:** United States

**Facility:** Sulpizio Cardiovascular Center

**State:** California

**Zip:** 92037

#### Overall Officials

**Official 1:**

**Affiliation:** UC San Diego

**Name:** Gregory Feld, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Wood MA, Orlov M, Ramaswamy K, Haffajee C, Ellenbogen K; Stereotaxis Heart Study Investigators. Remote magnetic versus manual catheter navigation for ablation of supraventricular tachycardias: a randomized, multicenter trial. Pacing Clin Electrophysiol. 2008 Oct;31(10):1313-21. doi: 10.1111/j.1540-8159.2008.01183.x.

**PMID:** 18811813

**Citation:** Proietti R, Pecoraro V, Di Biase L, Natale A, Santangeli P, Viecca M, Sagone A, Galli A, Moja L, Tagliabue L. Remote magnetic with open-irrigated catheter vs. manual navigation for ablation of atrial fibrillation: a systematic review and meta-analysis. Europace. 2013 Sep;15(9):1241-8. doi: 10.1093/europace/eut058. Epub 2013 Apr 12.

**PMID:** 23585253

**Citation:** Hlivak P, Mlcochova H, Peichl P, Cihak R, Wichterle D, Kautzner J. Robotic navigation in catheter ablation for paroxysmal atrial fibrillation: midterm efficacy and predictors of postablation arrhythmia recurrences. J Cardiovasc Electrophysiol. 2011 May;22(5):534-40. doi: 10.1111/j.1540-8167.2010.01942.x. Epub 2010 Nov 23.

**PMID:** 21091964

**Citation:** Feld G, Wharton M, Plumb V, Daoud E, Friehling T, Epstein L; EPT-1000 XP Cardiac Ablation System Investigators. Radiofrequency catheter ablation of type 1 atrial flutter using large-tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator: results of a multicenter safety and efficacy study. J Am Coll Cardiol. 2004 Apr 21;43(8):1466-72. doi: 10.1016/j.jacc.2003.11.036.

**PMID:** 15093885

**Citation:** Sawhney N, Anousheh R, Chen WC, Narayan S, Feld GK. Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol. 2009 Aug 1;104(3):366-72. doi: 10.1016/j.amjcard.2009.03.044. Epub 2009 Jun 6.

**PMID:** 19616669

**Citation:** Steinberg JS, Palekar R, Sichrovsky T, Arshad A, Preminger M, Musat D, Shaw RE, Mittal S. Very long-term outcome after initially successful catheter ablation of atrial fibrillation. Heart Rhythm. 2014 May;11(5):771-6. doi: 10.1016/j.hrthm.2014.02.003. Epub 2014 Feb 4.

**PMID:** 24508206

**Citation:** Akca F, Janse P, Theuns DA, Szili-Torok T. A prospective study on safety of catheter ablation procedures: contact force guided ablation could reduce the risk of cardiac perforation. Int J Cardiol. 2015 Jan 20;179:441-8. doi: 10.1016/j.ijcard.2014.11.105. Epub 2014 Nov 13.

**PMID:** 25465303

**Citation:** Sigmund E, Puererfellner H, Derndorfer M, Kollias G, Winter S, Aichinger J, Nesser HJ, Martinek M. Optimizing radiofrequency ablation of paroxysmal and persistent atrial fibrillation by direct catheter force measurement-a case-matched comparison in 198 patients. Pacing Clin Electrophysiol. 2015 Feb;38(2):201-8. doi: 10.1111/pace.12549. Epub 2014 Dec 2.

**PMID:** 25469738

**Citation:** Jarman JWE, Panikker S, DAS M, Wynn GJ, Ullah W, Kontogeorgis A, Haldar SK, Patel PJ, Hussain W, Markides V, Gupta D, Schilling RJ, Wong T. Relationship between contact force sensing technology and medium-term outcome of atrial fibrillation ablation: a multicenter study of 600 patients. J Cardiovasc Electrophysiol. 2015 Apr;26(4):378-384. doi: 10.1111/jce.12606. Epub 2015 Feb 11.

**PMID:** 25546580

**Citation:** le Polain de Waroux JB, Weerasooriya R, Anvardeen K, Barbraud C, Marchandise S, De Meester C, Goesaert C, Reis I, Scavee C. Low contact force and force-time integral predict early recovery and dormant conduction revealed by adenosine after pulmonary vein isolation. Europace. 2015 Jun;17(6):877-83. doi: 10.1093/europace/euu329. Epub 2015 Jan 24.

**PMID:** 25618742

**Citation:** Arujuna A, Karim R, Zarinabad N, Gill J, Rhode K, Schaeffter T, Wright M, Rinaldi CA, Cooklin M, Razavi R, O'Neill MD, Gill JS. A randomized prospective mechanistic cardiac magnetic resonance study correlating catheter stability, late gadolinium enhancement and 3 year clinical outcomes in robotically assisted vs. standard catheter ablation. Europace. 2015 Aug;17(8):1241-50. doi: 10.1093/europace/euu364. Epub 2015 Feb 16.

**PMID:** 25687748

**Citation:** Shurrab M, Danon A, Lashevsky I, Kiss A, Newman D, Szili-Torok T, Crystal E. Robotically assisted ablation of atrial fibrillation: a systematic review and meta-analysis. Int J Cardiol. 2013 Nov 5;169(3):157-65. doi: 10.1016/j.ijcard.2013.08.086. Epub 2013 Sep 10.

**PMID:** 24063921

**Citation:** Lopez-Gil M, Salgado R, Merino JL, Datino T, Figueroa J, Arenal A, Mejia E, Salguero R, Fontenla A, Arribas F. Cavo-tricuspid isthmus radiofrequency ablation using a novel remote navigation catheter system in patients with typical atrial flutter. Europace. 2014 Apr;16(4):558-62. doi: 10.1093/europace/eut285. Epub 2013 Sep 20.

**PMID:** 24058180

**Citation:** Datino T, Arenal A, Pelliza M, Hernandez-Hernandez J, Atienza F, Gonzalez-Torrecilla E, Avila P, Bravo L, Fernandez-Aviles F. Comparison of the safety and feasibility of arrhythmia ablation using the Amigo Robotic Remote Catheter System versus manual ablation. Am J Cardiol. 2014 Mar 1;113(5):827-31. doi: 10.1016/j.amjcard.2013.11.030. Epub 2013 Dec 12.

**PMID:** 24440330

**Citation:** Zhang W, Jia N, Su J, Lin J, Peng F, Niu W. The comparison between robotic and manual ablations in the treatment of atrial fibrillation: a systematic review and meta-analysis. PLoS One. 2014 May 6;9(5):e96331. doi: 10.1371/journal.pone.0096331. eCollection 2014.

**PMID:** 24800808

**Citation:** Wutzler A, Wolber T, Parwani AS, Huemer M, Attanasio P, Blaschke F, Haegeli L, Haverkamp W, Duru F, Boldt LH. Robotic ablation of atrial fibrillation with a new remote catheter system. J Interv Card Electrophysiol. 2014 Sep;40(3):215-9. doi: 10.1007/s10840-014-9895-x. Epub 2014 Apr 29.

**PMID:** 24771262

**Citation:** Thomas D, Scholz EP, Schweizer PA, Katus HA, Becker R. Initial experience with robotic navigation for catheter ablation of paroxysmal and persistent atrial fibrillation. J Electrocardiol. 2012 Mar;45(2):95-101. doi: 10.1016/j.jelectrocard.2011.05.005. Epub 2011 Jun 28.

**PMID:** 21714971

**Citation:** Hoffmayer KS, Krainski F, Shah S, Hunter J, Alegre M, Hsu JC, Feld GK. Randomized controlled trial of Amigo(R) robotically controlled versus manually controlled ablation of the cavo-tricuspid isthmus using a contact force ablation catheter. J Interv Card Electrophysiol. 2018 Mar;51(2):125-132. doi: 10.1007/s10840-018-0319-1. Epub 2018 Feb 12.

**PMID:** 29435790

## Document Section

### Large Document Module

#### Large Docs

- Date: 2015-03-19

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 276389

- Type Abbrev: Prot

- Upload Date: 2019-06-07T13:09

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4587

- Name: Atrial Flutter

- Relevance: HIGH

- As Found: Atrial Flutter

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

- ID: D000001282

- Term: Atrial Flutter

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Manual Catheter Manipulation

**Deaths Num At Risk:** 25

**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.

**ID:** EG000

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Manual Catheter Manipulation

**Group ID:** EG001

**Title:** Amigo™ Robotic Catheter Manipulation

**Deaths Num At Risk:** 25

**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.

**ID:** EG001

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Amigo™ Robotic Catheter Manipulation

**Frequency Threshold:** 0

**Time Frame:** From the time of enrollment to completion of the ablation procedure (which usually lasted 30-60 minutes).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Units:** Participants

### Group

**ID:** BG000

**Title:** Manual Catheter Manipulation

**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.

### Group

**ID:** BG001

**Title:** Amigo™ Robotic Catheter Manipulation

**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12

**Value:** 63

#### Measurement

**Group ID:** BG001

**Spread:** 12

**Value:** 63

#### Measurement

**Group ID:** BG002

**Spread:** 12

**Value:** 63

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 50

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** gfeld@ucsd.edu
**Organization:** University of California San Diego
**Phone:** (858) 246-2972
**Title:** Dr. Gregory Feld
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 179
- **Upper Limit:** 
- **Value:** 471
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 278
- **Upper Limit:** 
- **Value:** 571
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 3.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.4
- **Upper Limit:** 
- **Value:** 6.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At time of the ablation procedure, which typically lasts 30-60 minutes
**Title:** Contact Force Through Measurement of Force-time Integral (FTI)
**Type:** PRIMARY
**Unit of Measure:** gm/s
##### Group
**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.
**ID:** OG000
**Title:** Manual Catheter Manipulation
##### Group
**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.
**ID:** OG001
**Title:** Amigo™ Robotic Catheter Manipulation
#### Outcome Measure 2
**Description:** Determine fluoroscopy time to reach CTI block.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at time of ablation procedure
**Title:** Fluoroscopy Time Measurements
**Type:** SECONDARY
**Unit of Measure:** minutes
##### Group
**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.
**ID:** OG000
**Title:** Manual Catheter Manipulation
##### Group
**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.
**ID:** OG001
**Title:** Amigo™ Robotic Catheter Manipulation
### Participant Flow Module
#### Group
**Description:** 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.

Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.
**ID:** FG000
**Title:** Manual Catheter Manipulation
#### Group
**Description:** 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.

Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.
**ID:** FG001
**Title:** Amigo™ Robotic Catheter Manipulation
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True