Trials / Recruiting
RecruitingNCT05147792
The CONFORM Pivotal Trial
An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,600 (estimated)
- Sponsor
- Conformal Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CLAAS | CLAAS |
| DEVICE | WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder | WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder |
Timeline
- Start date
- 2022-05-26
- Primary completion
- 2028-06-01
- Completion
- 2031-12-01
- First posted
- 2021-12-07
- Last updated
- 2026-03-18
Locations
83 sites across 5 countries: United States, Czechia, France, Georgia, Uzbekistan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05147792. Inclusion in this directory is not an endorsement.