CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

NCT01984346 | Completed Results DMC

• 2 other identifiers: VAL-1200IDE Number G130084
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 27

Brief Summary

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation; Convergent Procedure; Combined Epicardial/ Endocardial Ablation; Hybrid Procedure; Radiofrequency Ablation; Arrhythmia; RF Ablation

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.

  This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.

  12 Months

• Primary Safety Analysis

  The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure.

  30 days

Secondary Outcomes (9)

• Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.

  12 month

• Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline

  12 Months

• AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.

  12 Months

• Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.

  12 Months

• Change in Atrial Fibrillation Severity Scale (AFSS)

  12 months

Study Arms (2)

Convergent Procedure

EXPERIMENTAL

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax; Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

Standalone Endocardial Catheter Ablation

ACTIVE COMPARATOR

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

Interventions

AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax DEVICE

Convergent Epicardial Endocardial Ablation Procedure

Also known as: Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation

Convergent Procedure

Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering DEVICE

Endocardial Catheter Ablation Procedure

Convergent Procedure; Standalone Endocardial Catheter Ablation

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; \< 80 years
• Left atrium \< 6.0 cm
• Refractory or intolerant to one AAD (class I and/or III)
• Documentation of persistent AF
• Provided written informed consent

You may not qualify if:

• Patients requiring concomitant surgery
• 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 transient Ischemic attack (TIA)
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices
• Patients with renal dysfunction who are not on dialysis
• Patients who are contraindicated for anticoagulants
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous left atrial catheter ablation for AF
• Patients with existing Implantable Cardioverter-Defibrillator (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 (27)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Heart Center Research LLC

Huntsville, Alabama, 35801, United States

Location

Rose Medical Center / Medical Center of Aurora

Denver, Colorado, 80220, 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

Mt Sinai Medical Center

Miami Beach, Florida, 33140, 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

St. Vincent Medical Group Inc.

Indianapolis, Indiana, 46260, United States

Location

Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, 70808, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University - Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Wake Medical Center / Cary Research Group

Raleigh, North Carolina, 27518, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Riverside Hospital / OhioHealth

Columbus, Ohio, 43214, United States

Location

UPMC Pinnacle Hospitals

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Austin Heart PLLC

Austin, Texas, 78756, United States

Location

STAR Clinical Trials LLC

San Antonio, Texas, 78229, 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

Related Publications (2)

• Gill J, Crossen KJ, Blauth C, Kerendi F, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp D, Osorio J, Tabereaux P, Boedefeld W, Civello K, Ahsan S, Yap J, Billakanty S, Duff S, Costantini O, Espinal E, Kiser A, Shults C, Pederson D, Garrison J, Gilligan DM, Link MG, Kowalski M, Stees C, Sperling JS, Jacobowitz I, Yang F, Greenberg YJ, De Lurgio DB. Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis. Ann Cardiothorac Surg. 2024 Mar 29;13(2):155-164. doi: 10.21037/acs-2023-afm-15. Epub 2023 Aug 29.

  PMID: 38590997 DERIVED

• DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.

  PMID: 33185144 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director of Clinical Education
• Organization: AtriCure

SGaynor@atricure.com

513-560-5974

Study Officials

• David DeLurgio, MD

  Emory St Joseph's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: 2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2023
• Last Updated: November 13, 2023
• Results First Posted: February 10, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (25)