Trials / Not Yet Recruiting
Not Yet RecruitingNCT07260474
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Detailed description
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patients implanted with Amplatzer Amulet™ | Left atrial appendage closure with the Amplatzer Amulet™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use. |
| DEVICE | Patients implanted with LAmbre™ | Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use. |
Timeline
- Start date
- 2026-01-30
- Primary completion
- 2026-12-31
- Completion
- 2027-01-31
- First posted
- 2025-12-03
- Last updated
- 2025-12-03
Source: ClinicalTrials.gov record NCT07260474. Inclusion in this directory is not an endorsement.