Clinical trial NCT03737929: Hybrid Therapy and Heart Team for Atrial Fibrillation
Official title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients with Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Epicardial surgical ablation
Percutaneous endocardial catheter ablation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2018-11-13
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
timeFrame: 12 months
Secondary outcomes:
measure: AF/AT recurrence or major complication
timeFrame: 12 months
measure: Major complication related to the procedure
timeFrame: 12 months
measure: Major complication related to AF/AT
timeFrame: 12 months
measure: Any complication (major or minor)
timeFrame: 12 months
measure: Redo-procedure
timeFrame: 12 months
measure: Cardioversion
timeFrame: 12 months
measure: Number of hospitalizations
timeFrame: 12 months
measure: Duration of the hospitalization
timeFrame: 1 month
measure: Radiation exposure time
timeFrame: 12 months
measure: Radiation exposure dosage
timeFrame: 12 months
measure: Antiarrhythmic drugs
timeFrame: 12 months
measure: Electrophysiological success
timeFrame: Day 0
measure: Evolution of quality of life
timeFrame: Between baseline to 12 months
measure: ICER
timeFrame: 12 months
measure: ICUR
timeFrame: 12 months
measure: Production costs
timeFrame: during the surgical procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Cardiology-rytmology
city: Toulouse
country: France
facility: CHU Toulouse, Hôpital Rangueil
city: Toulouse
country: France
facility: Cardiology-rytmology service
Study officials:
affiliation: University Hospital of Toulouse
name: Philippe Maury, MD
role: PRINCIPAL_INVESTIGATOR
References: