WAVECREST Post Market Clinical Follow-Up (PMCF) Study

Recruiting

Phase 3 Results N/A

Trial Description

The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.

Conditions

Interventions

  • Coherex WaveCrest® Left Atrial Appendage Occlusion System Device
    Intervention Desc: Left Atrial Appendage Closure
    ARM 1: Kind: Experimental
    Label: Treatment Group
    Description: Left Atrial Appendage (LAA) Closure with the WaveCrest LAA Occlusion System (study device)
  • Percutaneous LAA Closure Device
    Intervention Desc: LAA Closure with the WaveCrest LAA Occlusion System (study device)
    ARM 1: Kind: Experimental
    Label: LAA Occlusion

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of all-cause deaths and device and/or procedure related events while using the WaveCrest device 45 Days
Secondary Rate of successful device release within LAA as confirmed by TEE and fluoroscopy Intraoperative
Secondary Technical Success at implant Intraoperative
Secondary Procedural Success Intraoperative
Secondary Rate of successful device release within LAA Intraoperative

Sponsors