System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT05427435 on ClinicalTrials.gov

Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation

Official title: Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation

  • Sponsor: Hôpital Saint-André
  • Enrollment: 40 (Estimated)
  • Study start: 2022-05-09 (Actual)
  • Primary completion: 2027-05-16 (Estimated)
  • Study completion: 2027-05-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: prospective single arm monocentric evaluation study
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year 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 systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.

The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.

Conditions

  • Atrial Fibrillation

Intervention / Treatment

  • Device: Marshall ethanolisation

Primary Outcome Measures

  • Acute success rate of the procedure (12 months)
    Success rate complete realization of ethanolization procedure

Countries

France

Locations and Investigators

Study Officials

  • Nicolas MD DERVAL (Principal Investigator) — Study Principal Investigator