An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
Conformal Medical, Inc
Summary
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or non-pregnant female aged ≥18 years 2. Documented non-valvular AF (paroxysmal, persistent, or permanent) 3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3 4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation 5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy. 6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team…
Interventions
- DeviceCLAAS
CLAAS
- DeviceWATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Locations (88)
- Grandview Medical CenterBirmingham, Alabama
- Banner University Medical Center PhoenixPhoenix, Arizona
- Abrazo Arizona Heart HospitalPhoenix, Arizona
- Arizona Heart Arrhythmia AssociatesPhoenix, Arizona
- HonorHealthScottsdale, Arizona
- Pima Heart & VascularTucson, Arizona