Comparing two devices for preventing strokes in patients with atrial fibrillation
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
This study is testing two devices to see which one better prevents strokes in people with atrial fibrillation who can't take blood thinners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Deutsches Herzzentrum Muenchen Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06060912 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the safety and efficacy of two left atrial appendage occlusion (LAAO) devices, the LAmbre and the AMPLATZER Amulet, in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Eligible participants will be randomized to receive one of the two devices, and the primary outcome will be assessed by measuring peri-device leak size three months post-implantation using transesophageal echocardiography. The study is designed as a prospective, randomized, multi-center, open-label investigation, focusing on patients who cannot use long-term oral anticoagulation therapy. The results will help determine if the LAmbre device is as effective as the AMPLATZER Amulet in preventing strokes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented non-valvular atrial fibrillation at high risk for stroke, who are not eligible for long-term oral anticoagulation therapy.
Not a fit: Patients who require long-term oral anticoagulation therapy for conditions other than atrial fibrillation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective option for stroke prevention in patients with atrial fibrillation who cannot take long-term anticoagulants.
How similar studies have performed: Other studies have shown success with similar left atrial appendage occlusion devices, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and able to give consent * Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female) * Patient not eligible for long-term oral anticoagulation therapy * Deemed suitable for percutaneous LAAO * Able to comply with the required medication regimen after LAAO device implantation * Written informed consent * LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial) * For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study Exclusion Criteria: 1. Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve) 2. LAA is obliterated or surgically ligated 3. Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen 4. Prior atrial septal defect (ASD) repair or implantation of ASD closure device 5. Active endocarditis or other infection producing bacteremia 6. Significant symptomatic carotid artery disease 7. Participation in a concurrent clinical trial, which may confound the results of this trial 8. Patient cannot adhere to or complete the trial protocol for any reason Or any of the following echocardiographic exclusion criteria: 9. Intracardiac thrombus 10. Intracardiac tumor 11. Existing, clinically relevant circumferential pericardial effusion 12. Significant mitral valve stenosis
Where this trial is running
Munich, Bavaria
- Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Michael Joner, MD — Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München
- Study coordinator: Michael Joner, MD
- Email: joner@dhm.mhn.de
- Phone: +4989-1218-2869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.