Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03737929

Hybrid Therapy and Heart Team for Atrial Fibrillation

Led by University Hospital, Toulouse · Updated on 2024-10-23

228

Participants Needed

3

Research Sites

338 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Toulouse

Lead Sponsor

A

AtriCure, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Hybrid Therapy and Heart Team for Atrial Fibrillation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of symptomatic persistent atrial fibrillation lasting 7 days or more or long-standing persistent atrial fibrillation lasting more than 12 months
  • Refractory to or intolerant of at least one class I or III antiarrhythmic drug
  • At least 18 years of age
  • Willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Previous atrial fibrillation ablation procedure
  • Long-standing persistent atrial fibrillation longer than 3 years
  • Paroxysmal atrial fibrillation
  • Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or other reversible non-cardiovascular causes
  • Presence of left atrial appendage thrombus
  • Left atrial size 70 ml/m² or greater on transthoracic echocardiogram
  • Left ventricular ejection fraction less than 35%
  • Planned cardiac surgery (other than AF treatment) within 12 months
  • Contraindication to heparin or oral anticoagulation
  • Contraindication to transesophageal echocardiogram
  • Carotid stenosis greater than 80%
  • Active infection or sepsis
  • Pleural adhesions
  • Elevated hemidiaphragm
  • Untreated sleep apnea syndrome
  • Cerebrovascular accident or transient ischemic attack within the past 6 months
  • History of blood clotting abnormalities
  • Indication for permanent dual antiplatelet therapy
  • History of thoracic radiation
  • History of myocarditis, pericarditis, or cardiac tamponade
  • History of thoracotomy or cardiac surgery
  • Body mass index greater than 40 kg/m²
  • Significant lung dysfunction
  • Contraindication to anesthesia
  • Chronic obstructive pulmonary disease
  • Pregnancy
  • Life expectancy less than 12 months
  • Adults protected by law

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Cardiology-rytmology

Paris, France

Actively Recruiting

2

CHU Toulouse, Hôpital Rangueil

Toulouse, France, 31059

Actively Recruiting

3

Cardiology-rytmology service

Toulouse, France

Actively Recruiting

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Research Team

P

Philippe Maury, MD

CONTACT

D

Delphine Aravit

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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