Hybrid Therapy and Heart Team for Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Hybrid ablationProcedure: Percutaneous catheter ablation
- Registration Number
- NCT03737929
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hybrid ablation procedure Hybrid ablation In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure. Percutaneous endocardial catheter ablation procedure Percutaneous catheter ablation In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint).
- Primary Outcome Measures
Name Time Method Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence 12 months occurrence of at least one episode of AF/AT \> 30 seconds in any ECG or Holter tracing (absence or presence)
- Secondary Outcome Measures
Name Time Method Production costs during the surgical procedure Production costs of the two strategies using the micro-costing approach
Major complication related to AF/AT 12 months Percentage of patients developing a major complication related to AF/AT
Radiation exposure time 12 months Radiation exposure time (expressed in minutes) per patient. In case of redo-ablation during the follow-up, the total exposure time of the two first and the redo procedure will be totalized.
Antiarrhythmic drugs 12 months Percentage of patients requiring class I (flecainide ou propafenone) or III (sotalol ou amiodarone) antiarrhythmic drugs
AF/AT recurrence or major complication 12 months Percentage of patients developing a recurrence of AF/AT or a major complication (related to the procedure or related to AF/AT)
Major complication related to the procedure 12 months Percentage of patients developing a major complication related to the procedure
ICUR 12 months The incremental Cost-Utility Ratio (ICUR) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Redo-procedure 12 months Percentage of patients requiring a redo-procedure (new ablation in left atrium)
Cardioversion 12 months Percentage of patients requiring a cardioversion
Number of hospitalizations 12 months Number of hospitalizations for AF/AT recurrence or complications related to AF/AT or to the procedure
Radiation exposure dosage 12 months Radiation exposure dosage per patient. In case of redo-ablation during the follow-up, the total exposure dosage of the two first and the redo procedure will be totalized.
Any complication (major or minor) 12 months Percentage of patients developing any complication (major or minor) related to the procedure or related to AF/AT
Duration of the hospitalization 1 month Mean duration of the hospitalization for AF ablation
Electrophysiological success Day 0 Percentage of patients considered as reaching electrophysiological success, i.e. isolation of pulmonary veins and posterior box after epicardial surgical ablation. The validation will be performed during catheter ablation: isolation will be validated if there an entrance block in the posterior wall and in the pulmonary veins.
Evolution of quality of life Between baseline to 12 months Evolution of quality of life using the Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) scale. Symptom severity, physical and emotional components of quality of life, general well-being, and health care consumption related to AF are evaluated by this scale. The scale ranges from 0 to 4, corresponding to 0=no effect on functional quality of life to 4=a severe effect on life quality.
ICER 12 months The incremental cost-effectiveness ratio (ICER) of hybrid ablation versus catheter ablation, including long term evaluation with MARKOV modelling
Trial Locations
- Locations (3)
CHU Toulouse, Hôpital Rangueil
🇫🇷Toulouse, France
Cardiology-rytmology
🇫🇷Paris, France
Cardiology-rytmology service
🇫🇷Toulouse, France