TerminatedNot Applicable

Hybrid Therapy and Heart Team for Atrial Fibrillation

Stopped: Difficulty finding patients

France7 participantsStarted 2019-07-08

Plain-language summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold. Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results. Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.

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: * To have a history of symptomatic persistent atrial fibrillation (AF) (continuous AF lasting 7 days or more) or long-standing persistent AF (continuous AF lasting for more than 12 months) * To be refractory to or intolerant to at least one class I (flecainide / propafenone) or III (sotalol / amiodarone) antiarrhythmic drug, * To be at least 18 years of age, * To agree to participate (signature of the informed consent) Exclusion Criteria: * A previous AF ablation procedure, * A longstanding persistent AF \> 3 years, * A paroxysmal AF * AF consecutive to electrolyte imbalance, thyroid disease, or other reversible non-cardiovascular cause, * Presence of left atrial appendage (LAA) thrombus, * Left atrial size ≥ 70ml/m² on transthoracic echocardiogram (TTE), * Left ventricular ejection fraction \< 35%, * Cardiac surgery (other than AF treatment) planned within 12 months, * Contra-indication to heparin and/or oral anticoagulation * Contra-indication to transoesophageal echocardiogram (TEE) * Carotid stenosis \> 80%, * Active infection or sepsis * Pleural adhesions, * Elevated hemi diaphragm * Proven and untreated sleep apnoea syndrome, * Occurrence of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) during the past 6 months, * History of blood clotting abnormalities * Indication for a permanent dual antiplatelet therapy * History of thoracic radiation, * History of myocarditis or pericarditisHistory of cardiac tamponade, * History of th…

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

Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence

Timeframe: 12 months

Trial details

NCT IDNCT03737929

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-29

View on ClinicalTrials.gov More Atrial Fibrillation trials