NCT02239887

Coherex WAVECREST I Left Atrial Appendage Occlusion Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Coherex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.

Detailed description

Primary Safety Endpoint The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents as determined by the Clinical Events Committee (CEC) and include events such as device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; or any other event related to the device or the procedure, which requires treatment. Primary Efficacy Endpoint The primary efficacy endpoint is the incidence of LAA occlusion at 45 and/or 180 days (+ten days) post-procedure. LAA occlusion will be assessed by transesophageal echocardiography (TEE) color flow Doppler and will be defined as absence of flow in the LAA or color flow Doppler jets less than 3mm.

Conditions

• Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation
• LAA Anatomy Amenable to Treatment by Percutaneous Technique
• Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium

Interventions

Type	Name	Description
DEVICE	WaveCrest LAA occlusion device	Left Atrial Appendage Occlusion

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-09-15
• Last updated: 2015-01-15