CONVERGE Post-Approval Study (PAS) (NCT05393180) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CONVERGE Post-Approval Study (PAS)
United States53 participantsStarted 2022-04-13
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;