Hybrid Therapy and Heart Team for Atrial Fibrillation (HT2AF)

Toulouse University Hospital

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Hybrid ablation; Procedure: Percutaneous catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03737929

RC31/17/0449

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Hybrid ablation procedure

Experimental group

Description:

In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure.

Treatment:

Procedure: Hybrid ablation

Percutaneous endocardial catheter ablation procedure

Active Comparator group

Description:

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).

Treatment:

Procedure: Percutaneous catheter ablation