Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Abl… (NCT02695277) | Clinical Trial Compass
CompletedNot Applicable
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient has a history of symptomatic Persistent AF and a left atrium (LA) \> 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement
. Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
. Patient is mentally able and willing to give informed consent
Exclusion criteria
. Patient has longstanding persistent AF \> 10 years
. Patient presenting with paroxysmal AF
. Patient with persistent AF and a LA-diameter ≤ 4cm
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).
Timeframe: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
. Patient underwent previous ablation procedure or heart surgery
. Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)