Hybrid Therapy and Heart Team for Atrial Fibrillation

NCT03737929 | Recruiting DMC

• 1 other identifier: RC31/17/0449
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 3

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

Keywords

Epicardial surgical ablation; Percutaneous endocardial catheter ablation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence

  occurrence of at least one episode of AF/AT \> 30 seconds in any ECG or Holter tracing (absence or presence)

  12 months

Secondary Outcomes (16)

• AF/AT recurrence or major complication

  12 months

• Major complication related to the procedure

  12 months

• Major complication related to AF/AT

  12 months

• Any complication (major or minor)

  12 months

• Redo-procedure

  12 months

Study Arms (2)

Hybrid ablation procedure

EXPERIMENTAL

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

Procedure: Hybrid ablation

Percutaneous endocardial catheter ablation procedure

ACTIVE COMPARATOR

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).

Procedure: Percutaneous catheter ablation

Interventions

Hybrid ablation 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

Hybrid ablation procedure

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

Percutaneous endocardial catheter ablation procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• AtriCure, Inc.: collaborator

Study Sites (3)

Cardiology-rytmology

Paris, France

RECRUITING

CHU Toulouse, Hôpital Rangueil

Toulouse, 31059, France

RECRUITING

Cardiology-rytmology service

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Philippe Maury, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Maury, MD

CONTACT

05-61-32-34-56; maury.p@chu-toulouse.fr

Delphine Aravit

CONTACT

05 61 32 23 37; aravit.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 13, 2018
• Study Start: July 8, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)