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

Withdrawn before enrolling · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04239534

Run by

AtriCure, Inc.

People needed

0

Starts

2021-12-01

Expected to finish

2026-11-01

Last updated by the study team

2022-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
• Patient has presence of thrombus in the left atrium determined by intraoperative TEE.
• Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis.

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Heart Center Research LLC — Huntsville, Alabama, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• St. Vincent's HealthCare — Jacksonville, Florida, United States
• Palm Beach Gardens Medical Center — Palm Beach Gardens, Florida, United States
• Emory University - St. Joseph's Hospital — Atlanta, Georgia, United States
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
• Virginia Cardiovascular Specialists — Richmond, Virginia, United States
• St. Bartholomew's Hospital — London, United Kingdom
• Guy's and St. Thomas Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.