CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF

NCT04239534 | Withdrawn DMC FDA Device

• 1 other identifier: CP2019-1
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 10

Brief Summary

The objective of this clinical study is to collect additional data on the safety and effectiveness of the EPi- Sense®-AF Guided Coagulation System with VisiTrax® to treat symptomatic persistent or long-standing persistent Atrial Fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Conditions

Atrial Fibrillation

Keywords

Hybrid Procedure

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint- Freedom from Atrial Fibrillation, Atrial Tachycardia and Atrial Flutter

  The primary effectiveness endpoint is freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-months blanking period through the 12-months post procedure follow-up visit. The primary effectiveness endpoint will be evaluated from the 24-hours Holter.

  From Three month blanking period until 12-months post procedure follow-up visit.

• Primary Safety Endpoint- Evaluation of major adverse events (MAEs) from the procedure to 30-days post procedure.

  The primary safety endpoint for the study is the incidence of major adverse events (MAEs) for subjects undergoing the convergent procedure from the procedure to 30-days post procedure. The following MAEs occurring within 30 days of the procedure will contribute toward the primary safety endpoint: cardiac tamponade, severe pulmonary vein (PV) stenosis, excessive bleeding, myocardial infarction, Stroke, transient ischemic attacks (TIA), atrioesophageal fistula (AEF), phrenic nerve injury, and death.

  From procedure to 30-days post procedure

Secondary Outcomes (3)

• Effectiveness-Freedom for Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter and reduction of Atrial Fibrillation burden

  From 3-month blanking to 12-, 24- and 36- months post procedure evaluation

• Effectiveness- Atrial Fibrillation burden reduction

  From 3-month blanking to 12-, 24- and 36- months post procedure evaluation

• Safety-Incidence of serious adverse events

  Through 12-months post procedure visit

Study Arms (1)

Single Arm

OTHER

In this Single Arm Study, Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access. Followed by the sue of an endocardial ablation catheter that will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter.

Device: Convergence Of Epicardial And Endocardial RF Ablation

Interventions

Convergence Of Epicardial And Endocardial RF Ablation DEVICE

The epicardial lesion pattern will be created using the EPi-Sense®-AF Guided Coagulation System with VisiTrax®. Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi- Sense-AF Guided Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 80 years at time of enrollment consent.
• Left atrium ≤ 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view) or equivalent test.
• Refractory or intolerant to at least one AAD (class I and/or III).
• Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines.
• Provided written informed consent.

You may not qualify if:

• Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure.
• Left ventricular ejection fraction \< 40%.
• Pregnant or planning to become pregnant during study.
• Co-morbid medical conditions that limit one-year life expectancy.
• Previous cardiac surgery.
• History of pericarditis.
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA.
• Patients who have active infection or sepsis.
• Patients with esophageal ulcers strictures and varices.
• Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40).
• Patients who are contraindicated for anticoagulants such as heparin and coumadin.
• Patients who are being treated for ventricular arrhythmias.
• Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias).
• Patients with existing ICDs.
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (10)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Heart Center Research LLC

Huntsville, Alabama, 35801, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

St. Vincent's HealthCare

Jacksonville, Florida, 32204, United States

Location

Palm Beach Gardens Medical Center

Palm Beach Gardens, Florida, 33410, United States

Location

Emory University - St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

St. Bartholomew's Hospital

London, E1 1BB, United Kingdom

Location

Guy's and St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David De Lurgio, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Continued Access Protocol (CAP), prospective, multi-center, single arm study.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 27, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 27, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); GB (2)