## Protocol Section
### Identification Module
**NCT ID:** NCT04171479

**Acronym:** EPINAV

**Brief Title:** RMN Versus Manual Epicardial Retrospective PMCF

**Official Title:** A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques

#### Organization Study ID Info
**ID:** CLIN-024
#### Organization
**Class:** INDUSTRY
**Full Name:** Stereotaxis
### Status Module
#### Completion Date
**Date:** 2023-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-30

**Type:** ACTUAL

#### Start Date
**Date:** 2020-10-02

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2019-11-21
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-30
**Study First Submit QC Date:** 2019-11-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Stereotaxis

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.

**Detailed Description:** Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur.

### Conditions Module

**Conditions:**

- Ventricular Tachycardia

- Premature Ventricular Contraction

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.

**Intervention Names:**

- Device: Epicardial mapping and/or ablation

**Label:** Manual

#### Arm Group 2

**Description:** Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group.

**Intervention Names:**

- Device: Epicardial mapping and/or ablation

**Label:** Remote Magnetic Navigation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Manual

- Remote Magnetic Navigation

**Description:** Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

**Name:** Epicardial mapping and/or ablation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.

**Measure:** Acute Success

**Time Frame:** intra-operative

**Description:** Assess rates of device-and procedure-related serious adverse events in both groups.

**Measure:** Procedural Safety: rates of device-and procedure-related serious adverse events

**Time Frame:** 48 hours post index procedure

#### Secondary Outcomes

**Description:** Characterize recurrence rates for both groups at 1 year post index procedure.

**Measure:** Chronic Success

**Time Frame:** 1 year post index procedure

**Description:** Characterize rates of device-or procedure-related serious adverse events for both groups at 1 year post index procedure.

**Measure:** Chronic Safety: rates of device-or procedure-related serious adverse events

**Time Frame:** 1 year post index procedure

**Description:** Assess mortality rate for both groups

**Measure:** Mortality

**Time Frame:** 1 year post index procedure

**Description:** Characterize recurrence rates for both groups at last follow up.

**Measure:** Chronic Success

**Time Frame:** At last follow up visit, estimated up to 6 years post-procedure for some patients

**Description:** Characterize rates of device-or procedure-related serious adverse events for both groups at last follow up.

**Measure:** Chronic Safety: rates of device-or procedure-related serious adverse events

**Time Frame:** At last follow up visit, estimated up to 6 years post-procedure for some patients

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years of age or older
* Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
* Index procedure was conducted between July 1, 2013-present date.

Exclusion Criteria:

* NA, all subjects who meet inclusion criteria may be enrolled.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Prague

**Country:** Czechia

**Facility:** Na Homolce Hospital

**Location 2:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** OLVG Hospital

**Location 3:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus Medical Center

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005117

- Term: Cardiac Complexes, Premature

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M16384

- Name: Tachycardia

- Relevance: HIGH

- As Found: Tachycardia

- ID: M19488

- Name: Tachycardia, Ventricular

- Relevance: HIGH

- As Found: Ventricular Tachycardia

- ID: M20921

- Name: Ventricular Premature Complexes

- Relevance: HIGH

- As Found: Premature Ventricular Contractions

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

- ID: M8260

- Name: Cardiac Complexes, Premature

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013610

- Term: Tachycardia

- ID: D000017180

- Term: Tachycardia, Ventricular

- ID: D000018879

- Term: Ventricular Premature Complexes

### Misc Info Module

#### Removed Countries

- Country: Finland

- Country: Romania

- Version Holder: 2024-05-24
