## Protocol Section
### Identification Module
**NCT ID:** NCT00571779

**Acronym:** RESTORE SR IIB

**Brief Title:** AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

**Official Title:** Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

#### Organization Study ID Info
**ID:** CP2007-2
#### Organization
**Class:** INDUSTRY
**Full Name:** AtriCure, Inc.
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-02-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-02-18

**Overall Status:** WITHDRAWN

**Status Verified Date:** 2011-02

#### Study First Post Date
**Date:** 2007-12-12
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-10
**Study First Submit QC Date:** 2007-12-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AtriCure, Inc.

### Description Module

**Brief Summary:** Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).

### Conditions Module

**Conditions:**

- Atrial Fibrillation

### Design Module

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** AtriCure Bipolar System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.

**Measure:** The primary safety endpoint will be determined by assessing the rate of serious adverse events.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient between 18 and 80 years of age
2. Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.

   * Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
   * Longstanding AF: Persistent AF of 12 months (or longer) duration.
   * Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
3. Patient is willing and able to provide written informed consent.
4. Patient has a life expectancy of at least 2 years.
5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
2. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
3. Myocardial infarction within 8 weeks.
4. Prior cardiac surgery.
5. Patient requires cardiac surgery for treatment other than for AF.
6. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF
7. Cerebrovascular accident within previous 6 months
8. Known carotid artery stenosis greater than 80%
9. Evidence of significant active infection
10. Patient unable to undergo TEE
11. Pregnant woman
12. Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
13. Presence of thrombus in the left atrium
14. Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
15. Patient is enrolled in another cardiac clinical trial
16. Left ventricular ejection fraction \< 30%
17. Left atrial transverse diameter \>6.0
18. Patient has undergone previous thoracic targeted radiation

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## 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: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24
