CompletedNot Applicable

Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

France12 participantsStarted 2015-09

Plain-language summary

The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation. This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time. This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.

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: patients with complex AF defined by the following criteria : * AF\> 1 week or long term persistent\> 1 year * AND Symptomatic * AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic Exclusion Criteria: The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF: * Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated) * Recent AF for which a simple gesture is intracavitary considered sufficient * Permanent AF * Asymptomatic AF * Very old AF (\> 5 years) or atrial major ectasia (\> 60 mm) * Need another surgery (valve bypass coronary) * Previous history of sternotomy or thoracotomy * High-risk surgical or anesthetic Patient * BMI\> 35 * Sleep Apnea * Ejection fraction \<35% * Thoracic trauma history * Veins Pulmonary stenosis\> 50% * Hyperthyroidism * Thrombus in LAA

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

Number of participants with complete procedure or not

Timeframe: 3 hours

Trial details

NCT IDNCT02630914

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials