Hybrid Therapy and Heart Team for Atrial Fibrillation

NCT ID: NCT03737929

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2025-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid ablation procedure

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

Group Type: EXPERIMENTAL

Hybrid ablation

Intervention Type: PROCEDURE

In the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm

Percutaneous endocardial catheter ablation procedure

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).

Group Type: ACTIVE_COMPARATOR

Percutaneous catheter ablation

Intervention Type: PROCEDURE

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. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise).

Interventions

Hybrid ablation

In the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm

Intervention Type: 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. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Maury, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

Cardiology-rytmology

Paris, , France

Site Status: RECRUITING

CHU Toulouse, Hôpital Rangueil

Toulouse, , France

Site Status: RECRUITING

Cardiology-rytmology service

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe Maury, MD

Role: CONTACT

maury.p@chu-toulouse.fr

05-61-32-34-56 ext. +33

Delphine Aravit

Role: CONTACT

aravit.d@chu-toulouse.fr

05 61 32 23 37 ext. +33

Facility Contacts

Estelle GANDJBAKHCH

Role: primary

estelle.gandjbakhch@aphp.fr

Philippe Maury, MD

Role: primary

maury.p@chu-toulouse.fr

05 61 32 34 56 ext. +33

Anne Rollin, MD

Role: backup

rollin.a@chu-toulouse.fr

Philippe Maury, MD

Role: backup

Anne Rollin, MD

Role: backup

Bertrand Marcheix, MD

Role: backup

Etienne Grunenwald, MD

Role: backup

Stephane COMBES

Role: primary

smbech@clinique-pasteur.com

5 62 21 16 45 ext. +33

Issam ABOULIATIM

Role: backup

smccvt@clinique-pasteur.com

5 62 21 16 04 ext. +33

Other Identifiers

RC31/17/0449

Identifier Type: -

Identifier Source: org_study_id