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Clinical Trials/NCT03737929
NCT03737929
Recruiting
Not Applicable

Comparison of the Efficacy of Hybrid Ablative Therapy for Patients with Persistent Atrial Fibrillation Versus Conventional Catheter Ablation

University Hospital, Toulouse3 sites in 1 country228 target enrollmentJuly 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University Hospital, Toulouse
Enrollment
228
Locations
3
Primary Endpoint
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2019
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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

Time Frame: 12 months

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

Secondary Outcomes

  • Radiation exposure time(12 months)
  • Antiarrhythmic drugs(12 months)
  • AF/AT recurrence or major complication(12 months)
  • Major complication related to the procedure(12 months)
  • Major complication related to AF/AT(12 months)
  • ICUR(12 months)
  • Redo-procedure(12 months)
  • Cardioversion(12 months)
  • Number of hospitalizations(12 months)
  • Radiation exposure dosage(12 months)
  • Any complication (major or minor)(12 months)
  • Duration of the hospitalization(1 month)
  • Electrophysiological success(Day 0)
  • Evolution of quality of life(Between baseline to 12 months)
  • ICER(12 months)
  • Production costs(during the surgical procedure)

Study Sites (3)

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