CompletedNot Applicable

Hybrid Versus Catheter Ablation in Persistent AF

Netherlands41 participantsStarted 2016-10-31

Plain-language summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold. Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set. The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Who can participate

Age range

18 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: * Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation, * Refractory to or intolerant of at least one antiarrhythmic drug class I or III, * At least 18 years of age, * Mentally able and willing to give informed consent. Exclusion Criteria: * Previous ablation procedure, * Longstanding persistent AF \> 3 years, * Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize, * Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause, * Presence of left atrial appendage (LAA) thrombus, * Left atrial size ≥ 60mm (PLAX-view on TEE), * Left ventricular ejection fraction \< 40%, * In need for other cardiac surgery then AF treatment within 12 months, * Intolerance to heparin and warfarin, * Unable to undergo TEE, * Sick-sinus-syndrome * Mitral valve insufficiency \> Iº * Carotic stenosis \> 80%, * Active infection or sepsis, * Pleural adhesions, * Elevated hemi diaphragm * Significant pulmonary dysfunction as assessed by preoperative lung testing, * Chronic obstructive pulmonary disease with a FEV1 or VC \< 50% predicted * History of cerebrovascular accident (CVA) or transient ischemic attack (TIA), * History of blood clotting abnormalities, * History of thoracic radiation, * History o…

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

Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.

Timeframe: 12 Months

Major complications during follow-up

Timeframe: 12 Months

Trial details

NCT IDNCT02441738

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Atrial Fibrillation trials