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Persistent Atrial FibrillationCONVERGENCT01984346

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

A study testing AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax and Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering in people with Persistent Atrial Fibrillation, run by AtriCure, Inc. at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax and Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
27 sitesin 2 countries
Study dates
Dec 2013to Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Not competent to legally represent him or herself

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States25 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Emory University - St. Joseph's Hospital

    Atlanta, Georgia, 30342

  • Austin Heart PLLC

    Austin, Texas, 78756

  • Cardiovascular Research Foundation of Louisiana

    Baton Rouge, Louisiana, 70808

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Riverside Hospital / OhioHealth

    Columbus, Ohio, 43214

  • Rose Medical Center / Medical Center of Aurora

    Denver, Colorado, 80220

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • East Carolina University - Vidant Medical Center

    Greenville, North Carolina, 27834

  • UPMC Pinnacle Hospitals

    Harrisburg, Pennsylvania, 17101

  • Heart Center Research LLC

    Huntsville, Alabama, 35801

  • St. Vincent Medical Group Inc.

    Indianapolis, Indiana, 46260

  • St. Vincent's HealthCare

    Jacksonville, Florida, 32204

  • Mt Sinai Medical Center

    Miami Beach, Florida, 33140

  • Palm Beach Gardens Medical Center

    Palm Beach Gardens, Florida, 33410

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Wake Medical Center / Cary Research Group

    Raleigh, North Carolina, 27518

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23229

  • STAR Clinical Trials LLC

    San Antonio, Texas, 78229

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

United Kingdom2 sites

  • St. Bartholomew's Hospital

    London, E1 1BB

  • Guy's and St. Thomas Hospital

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

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).

Read the detailed description

The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.

The primary efficacy endpoint is success or failure to be AF/AT/AFL free 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-month blanking period through the 12-month post procedure follow-up visit.

The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.

Being tested
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax, Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Keywords
Atrial Fibrillation, Convergent Procedure, Combined Epicardial/ Endocardial Ablation, Hybrid Procedure, Radiofrequency Ablation, Arrhythmia, RF Ablation
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtriCure EPi-Sense-AF Guided Coagulation System with VisiTraxDevice

    Also called Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation

    Convergent Epicardial Endocardial Ablation Procedure

  • Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steeringDevice

    Endocardial Catheter Ablation Procedure

Study groups in NCT01984346
Study groupRoleWhat they receive
Convergent ProcedureExperimentalProcedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
Receives: 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 AblationActive comparatorProcedure/Surgery: Endocardial Catheter Ablation Treatment
Receives: Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 Months

  2. 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.

    Measured: 30 days

Secondary outcomes (9)

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

    The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure.

    Measured: 12 month

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

    AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline.

    Measured: 12 Months

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

    Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's

    Measured: 12 Months

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

    Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.

    Measured: 12 Months

  5. Change in Atrial Fibrillation Severity Scale (AFSS)

    Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden.

    Measured: 12 months

  6. Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)

    Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.

    Measured: 12 Months

  7. Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)

    Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.

    Measured: 12 months

  8. Change in 6-Minute Walk Score

    6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.

    Measured: 12 months

  9. Change in Left Atrial Diameter

    Change in Left Atrial Diameter at 6 months from baseline.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2019
  4. Study completionOct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01984346
Sponsor's protocol ID
VAL-1200
Other IDs
IDE Number G130084
Acronym
CONVERGE
Status last verified
Nov 2023
First submitted
7 Nov 2013
Last updated
13 Nov 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38590997

  • 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.

    PubMed 33185144

Questions about this trial

What is this clinical trial studying?

A study testing AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax and Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering in people with Persistent Atrial Fibrillation, run by AtriCure, Inc. at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01984346, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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