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

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT01984346

Run by

AtriCure, Inc.

People needed

170

Starts

2013-12-01

Expected to finish

2023-10-01

Last updated by the study team

2023-11-13

Who can join

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

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
• Not competent to legally represent him or herself

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Heart Center Research LLC — Huntsville, Alabama, United States
• Rose Medical Center / Medical Center of Aurora — Denver, Colorado, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• St. Vincent's HealthCare — Jacksonville, Florida, United States
• Mt Sinai Medical Center — Miami Beach, Florida, United States
• Palm Beach Gardens Medical Center — Palm Beach Gardens, Florida, United States
• Emory University - St. Joseph's Hospital — Atlanta, Georgia, United States
• St. Vincent Medical Group Inc. — Indianapolis, Indiana, United States
• Cardiovascular Research Foundation of Louisiana — Baton Rouge, Louisiana, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Staten Island University Hospital — Staten Island, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University - Vidant Medical Center — Greenville, North Carolina, United States
• Wake Medical Center / Cary Research Group — Raleigh, North Carolina, United States
• Summa Health System — Akron, Ohio, United States
• Riverside Hospital / OhioHealth — Columbus, Ohio, United States
• UPMC Pinnacle Hospitals — Harrisburg, Pennsylvania, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Austin Heart PLLC — Austin, Texas, United States
• STAR Clinical Trials LLC — San Antonio, Texas, United States
• Virginia Cardiovascular Specialists — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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