CONVERGE Post-Approval Study (PAS)

NCT05393180 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP2021-1
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 13

Brief Summary

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Conditions

Chronic Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.

  Primary Effectiveness Endpoint: The primary effectiveness endpoint is defined as the number of participants that exhibit 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 90-day blanking period through the 12-months post procedure follow-up visit. The primary effectiveness endpoint will be evaluated based on the first 24 hours of the 7-days Holter monitoring. Participants will be considered failures if any of the following conditions are observed: AF/AFL/AT greater than 30 seconds, new or increased dose of previously failed AAD through 12 month post procedure visit, Cardioversion through 12 months post procedure, left sided catheter ablation through 12 months post procedure and catheter ablation for right sided typical atrial flutter. Failures will be compared to total cohort to establish a success rate.

  1 year

• Primary Safety Endpoint, Incidence of defined Major Adverse Events

  The primary safety endpoint for the study is defined as the number of participants that exhibit device or procedure-related major adverse events (MAEs) for subjects undergoing the Hybrid Convergent procedure from the index procedure through 30-days post procedure. Participants will be considered failures if the following is exhibted: * Pericardial effusions with cardiac tamponade defined as effusions resulting in hemodynamic compromise. * Severe pulmonary vein (PV) stenosis * Excessive bleeding requiring reoperation * Myocardial infarction (MI); * Stroke, transient ischemic attacks (TIA); * Atrioesophageal fistula (AEF) through 3-months post-procedure; * Phrenic nerve injury * Death Failures will be compared to total cohort of participants to establish success rate.

  30-days post procedure

Secondary Outcomes (9)

• Incidence of significant pericardial effusion

  12 months

• Incidence of Serious Adverse Events (SAE) through 12 months

  12 months

• Increase or decrease in AF symptoms from baseline

  3 years

• Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD

  12 months

• Freedom from any AF/AFL/AT >30 seconds without a Class I/III

  3 years

Study Arms (1)

Hybrid Convergent

OTHER

Once the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System 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 complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®- Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.

Device: Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF

Interventions

Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF DEVICE

Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. .

Hybrid Convergent

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 assessed with Transthoracic Echocardiography \[TTE\] with parasternal 4 chamber view or equivalent imaging modality;
• Refractory or intolerant to at least one AAD (class I and/or III);
• Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (\> 12 months of continuous AF);
• Life expectancy \> 12 months; and
• Provides 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 \< 35%;
• 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 more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions;
• 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 (e.g., requires a guardian or caretaker as a legal representative);

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (13)

Sutter Bay Hospitals

San Francisco, California, 94107, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Baycare Health Systems

Clearwater, Florida, 33759, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Emory Saint Joseph Hopsital

Atlanta, Georgia, 30322, United States

Location

Wellstar Health System

Marietta, Georgia, 30062, United States

Location

Norton Heart & Vascular Institute

Louisville, Kentucky, 40205, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Southcoast Hospitals Group

New Bedford, Massachusetts, 02740, United States

Location

AtlantiCare Medical Center

Atlantic City, New Jersey, 08401, United States

Location

Avera Heart Hospital of SD

Sioux Falls, South Dakota, 57108, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

St Thomas

London, Se1 7EH, United Kingdom

Location

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: Prospective, multi-center, open-label, single arm (Hybrid Convergent only) post-approval study

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: May 26, 2022
• Study Start: April 13, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 21, 2028
• Last Updated: April 22, 2026

Record last verified: 2025-10

Locations

GB (1); US (12)