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

NCT07349121 on ClinicalTrials.gov

OPTION-EMEA Clinical Trial

Official title: Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]

  • Sponsor: Boston Scientific (United States)
  • Enrollment: 500 (Estimated)
  • Study start: 2026-06-18 (Actual)
  • Primary completion: 2028-12-01 (Estimated)
  • Study completion: 2029-12-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.

The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.

Conditions

  • Atrial Fibrillation (AF)
  • Stroke Prevention in Patients With Atrial Fibrillation
  • Left Atrial Appendage Closure
  • Pulsed Field Ablation
  • Atrial Fibrillation Ablation Procedure
  • Concomitant Procedures

Intervention / Treatment

  • Device: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case
  • Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure

Primary Outcome Measures

  • Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events (30 days following the index procedure.)
    The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.
  • Primary Efficacy Endpoint (PEE): Acute Treatment Success (Through 30 days)
    The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.

Countries

Belgium, Croatia, France, Italy, Spain

Locations and Investigators

  • AZORG - Hospital, Aalst, Belgium (Recruiting)
    • Thomas De Potter, MD (Principal Investigator)
  • UZ Brussel (AZ VUB), Brussels, Belgium (Recruiting)
    • Domenico Della Rocca, MD (Principal Investigator)
  • Klinicki bolnicki centar Zagreb, Zagreb, Croatia (Recruiting)
    • Vedran Velagic, MD (Principal Investigator)
  • CHRU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
    • Romain Eschalier, MD (Principal Investigator)
  • Centre Cardiologique du Nord, Saint-Denis, France (Recruiting)
    • Antoine Lepillier, MD (Principal Investigator)
  • Clinique Pasteur - Toulouse, Toulouse, France (Recruiting)
    • Serge Boveda, MD (Principal Investigator)
  • Centro Cardiologico Monzino, Milan, Italy (Recruiting)
    • Claudio Tondo, MD (Principal Investigator)
  • IRCCS Policlinico San Donato, San Donato Milanese, Italy (Recruiting)
    • Carlo Pappone, MD (Principal Investigator)
  • University Hospital of Salamanca, Salamanca, Spain (Not yet recruiting)
    • Ignacio Cruz-Gonzalez, MD (Principal Investigator)
  • Hospital Universitario La Fe, Valencia, Spain (Recruiting)
    • Joaquín Osca Asensi, MD (Principal Investigator)
  • Hospital Alvaro Cunqueiro, Vigo, Spain (Recruiting)
    • Maria Cespon Fernandez, MD (Principal Investigator)