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Studies

Interventional Active not recruiting

NCT04681872 on ClinicalTrials.gov

Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation

  • Sponsor: Hôpital Saint-André
  • Enrollment: 262 (Actual)
  • Study start: 2021-09-20 (Actual)
  • Primary completion: 2027-09-20 (Estimated)
  • Study completion: 2027-09-20 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: The Marshall Plan is a prospective randomized, parallel-group, multicenter clinical trial of superiority
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan).

Conditions

  • Atrial Fibrillation

Intervention / Treatment

  • Procedure: Destruction of Marshall bundles
  • Procedure: Pulmonary veins isolation
  • Procedure: Linear ablation in the left and right atria

Primary Outcome Measures

  • Recurrence of AF or Atrial Tachycardia (AT) greater than 30 seconds with or without antiarrhythmic medications after a single ablation procedure (2 years)
    Recurrence rate (percentage) of AF or AT \> 30 seconds after the blanking period of 3-months post ablation, at 2 years with or without antiarrhythmic medications after a single ablation procedure. Recurrences will be identified through transtelephonic electrocardiogram (ECG) monitor with weekly transmitted ECG and at any time in case of symptoms.

Countries

Belgium, France

Locations and Investigators

  • AZ Sint Jan Brugge, Brugge, Belgium
  • Clinique Saint Augustin, Bordeaux, France
  • Clermont-Ferrand University Hospital, Clermont-Ferrand, France
  • Ambroise Paré Hospital, Neuilly-sur-Seine, France
  • Les Franciscaines Hospital, Nîmes, France
  • Bordeaux University Hospital, Pessac, France
  • Centre Cardiologique du Nord, Saint-Denis, France
  • Clinique Pasteur, Toulouse, France
  • Toulouse University Hospirtal, Toulouse, France

Study Officials