Hybrid therapy for treating atrial fibrillation
Comparison of the Efficacy of Hybrid Ablative Therapy for Patients with Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
This study is testing a new treatment that combines surgery and a catheter procedure to help people with persistent atrial fibrillation who haven't found relief with regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT03737929 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a hybrid approach combining surgical and catheter ablation techniques for patients with persistent atrial fibrillation (AF). The study aims to improve treatment outcomes for individuals who have not responded to traditional antiarrhythmic medications. Participants will undergo a minimally invasive thoracoscopic surgical procedure alongside percutaneous catheter ablation to enhance the success rates of AF management. The trial is designed to evaluate the effectiveness and safety of this combined treatment method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic persistent atrial fibrillation who have not responded to at least one antiarrhythmic drug.
Not a fit: Patients with a history of previous AF ablation procedures or those with longstanding persistent AF greater than 3 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and outcomes for patients suffering from persistent atrial fibrillation.
How similar studies have performed: Previous studies have shown promising results with hybrid ablation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 thoracotomy or cardiac surgery, * Body-mass-index \> 40 kg/m2, * Significant lung dysfunction * Contra-indication to anesthesia * Patient with chronic obstructive pulmonary disease (COPD) * Pregnancy, * Life expectancy less than 12 months, * Adults protected by the law
Where this trial is running
Paris and 2 other locations
- Cardiology-rytmology — Paris, France (Recruiting)
- CHU Toulouse, Hôpital Rangueil — Toulouse, France (Recruiting)
- Cardiology-rytmology service — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Philippe Maury, MD — University Hospital of Toulouse
- Study coordinator: Philippe Maury, MD
- Email: maury.p@chu-toulouse.fr
- Phone: 05-61-32-34-56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.