Comparing two devices for preventing strokes in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.