NCT06060912Recruiting
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy. The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 11 Sept 2023
- Start date
- 5 Dec 2023
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Diseases
- Stroke
- NCT number
- NCT06060912
What you commit to
- Study type: Interventional
- Planned participants: 226
- From 5 Dec 2023 to the primary completion date, 15 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior atrial septal defect (ASD) repair or implantation of ASD closure device
- Participation in a concurrent clinical trial, which may confound the results of this trial
Other illness
- Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
- Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
- Active endocarditis or other infection producing bacteremia
- Significant symptomatic carotid artery disease
Other
- LAA is obliterated or surgically ligated
- Patient cannot adhere to or complete the trial protocol for any reason
- Or any of the following echocardiographic exclusion criteria:
- Intracardiac thrombus
- Intracardiac tumor
- Existing, clinically relevant circumferential pericardial effusion
- Significant mitral valve stenosis
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.