LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Recruiting
N/A
Interventional Study
Left Atrial Appendage Occlusion
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 226 (estimated)
- Sponsor
- Deutsches Herzzentrum Muenchen · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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-t…
Contacts