CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF
Megadott ok: Start-up and enrolling activities have been suspended and study closed
Key facts
- Where
- Atlanta, Birmingham, Huntsville, Jacksonville, Palm Beach Gardens, Richmond, Tupelo és Washington D.C., Egyesült ÁllamokSee the 8 sites
Where in Egyesült Államok
- Emory University - St. Joseph's HospitalAtlanta, Egyesült ÁllamokNo longer taking part
- Grandview Medical CenterBirmingham, Egyesült ÁllamokNo longer taking part
- Heart Center Research, LLCHuntsville, Egyesült ÁllamokNo longer taking part
- St. Vincent's HealthcareJacksonville, Egyesült ÁllamokNo longer taking part
- Palm Beach Gardens Medical CenterPalm Beach Gardens, Egyesült ÁllamokNo longer taking part
- Virginia Cardiovascular SpecialistsRichmond, Egyesült ÁllamokNo longer taking part
- Cardiology Associates Research, LLcTupelo, Egyesült ÁllamokNo longer taking part
- MedStar Washington Hospital CenterWashington D.C., Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- AtriCure, Inc.
- Trial code
- NCT04239534
- Record updated
- 2022. július 27.
- Original description
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.Read full original descriptionShow less
Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
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.
Inclusion: 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.
Exclusion: Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure; Previous cardiac surgery; Previous cerebrovascular accident (CVA), excluding fully resolved TIA; Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias); 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; Co-morbid medical conditions that limit one-year life expectancy; History of pericarditis; Patients who have active infection or sepsis; Patients who are being treated for ventricular arrhythmias; Left ventricular ejection fraction < 40%; Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40); Pregnant or planning to become pregnant during study; Patients with esophageal ulcers strictures and varices; Patients who are contraindicated for anticoagulants such as heparin and coumadin; Patients with existing ICDs; 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.