Informations générales (source: ClinicalTrials.gov)
Comparison of the Efficacy of Hybrid Ablative Therapy for Patients with Persistent Atrial Fibrillation Versus Conventional Catheter Ablation (HT2AF)
Interventional
N/A
University Hospital, Toulouse (Voir sur ClinicalTrials)
juillet 2019
décembre 2025
24 octobre 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Toulouse, Hôpital Rangueil - 31059 - Toulouse - France | Philippe Maury, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cardiology-rytmology - Paris - France | Estelle GANDJBAKHCH | Contact (sur clinicalTrials) | |||
| Cardiology-rytmology service - Toulouse - France | Stephane COMBES | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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