Clinical trial NCT05393180: CONVERGE Post-Approval Study (PAS)
Official title: Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label, single arm (Hybrid Convergent only) post-approval study
Primary purpose: TREATMENT

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.

Detailed description: In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial.

Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold.

The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients.

The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options.

A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to:

1. Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals.
2. Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates.
3. Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience.

Collect and report on long term outcomes of the Hybrid Convergent procedure.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and \< 80 years at time of enrollment consent;
2. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography \[TTE\] with parasternal 4 chamber view or equivalent imaging modality;
3. Refractory or intolerant to at least one AAD (class I and/or III);
4. 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);
5. Life expectancy \> 12 months; and
6. Provides written informed consent.

Exclusion Criteria:

1. Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
2. Left ventricular ejection fraction \< 35%;
3. Pregnant or planning to become pregnant during study;
4. Co-morbid medical conditions that limit one-year life expectancy;
5. Previous cardiac surgery;
6. History of pericarditis;
7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
8. Patients who have active infection or sepsis
9. Patients with esophageal ulcers strictures and varices;
10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);
11. Patients who are contraindicated for anticoagulants such as heparin and coumadin;
12. Patients who are being treated for ventricular arrhythmias;
13. 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;
14. 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;
15. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative);
16. Patient has presence of thrombus in the left atrium determined by intraoperative TEE;
17. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins \>50 % stenosis;
18. Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study;
19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
20. Presence of Barretts esophagitis

Primary outcomes:
measure: Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.
timeFrame: 1 year
measure: Primary Safety Endpoint, Incidence of defined Major Adverse Events
timeFrame: 30-days post procedure
Secondary outcomes:
measure: Incidence of significant pericardial effusion
timeFrame: 12 months
measure: Incidence of Serious Adverse Events (SAE) through 12 months
timeFrame: 12 months
measure: Increase or decrease in AF symptoms from baseline
timeFrame: 3 years
measure: Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD
timeFrame: 12 months
measure: Freedom from any AF/AFL/AT >30 seconds without a Class I/III
timeFrame: 3 years
measure: Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD
timeFrame: 3 years
measure: Number of participants with a reduction of AF burden
timeFrame: 3 years
measure: Number of Participants with an decrease in AFEQT Questionnaire Quality of Life (Qol) Score
timeFrame: 3 years
measure: Number of participants with less than 30 seconds of AF/AFL/AT
timeFrame: 3 years
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Francisco
country: United States
facility: Sutter Bay Hospitals
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital System
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Baycare Health Systems
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory Saint Joseph Hopsital
state: Georgia
city: Marietta
country: United States
facility: Wellstar Health System
state: Georgia
city: Indianapolis
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Louisville
country: United States
facility: Norton Heart & Vascular Institute
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: New Bedford
country: United States
facility: Southcoast Hospitals Group
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Atlantic City
country: United States
facility: AtlantiCare Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: Northwell - North Shore University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of SD
state: South Dakota
city: Dallas
country: United States
facility: HCA Dallas North Texas Heart Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Stone Oak
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Midlothian
country: United States
facility: Bon Secours
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: London
country: United Kingdom
facility: St Thomas
Study officials:
References: