Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

AMPIRI is an investigator-initiated, prospective, randomized, multi-center, open-label, non-inferiority other clinical investigation. All consecutive patients with non-valvular AF at increased risk for stroke or systemic embolism based on CHA2DS2-VASc score not eligible for long-term oral anticoagulation therapy will qualify for screening. Patients with confirmed eligibility and who have given written informed consent will be randomized in a 1:1 fashion to group A (LAmbre LAAO device) or group B (AMPLATZER Amulet LAAO device). Clinical indication, technique, and timing of LAAO will be at the operator's discretion. 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 PDL size 3 months after LAAO, as assessed with TOE in patients with non-valvular AF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06060912
Study type Interventional
Source Deutsches Herzzentrum Muenchen
Contact Michael Joner, MD
Phone +4989-1218-2869
Email joner@dhm.mhn.de
Status Recruiting
Phase N/A
Start date December 5, 2023
Completion date October 15, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT03987945 - Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai
Completed NCT05632445 - Apixaban vs Dual Antiplatet Therapy Study After Left Atrial Appendage Occlosure (ADALA) Phase 4
Terminated NCT00841529 - Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage Phase 2
Recruiting NCT05554822 - Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study Phase 3
Not yet recruiting NCT04897204 - Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation N/A
Recruiting NCT04524741 - Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device N/A
Recruiting NCT04524780 - Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device. N/A
Withdrawn NCT05399342 - Left Atrial Appendage Occlusion Study III Extended Follow Up
Completed NCT05136417 - Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device N/A
Recruiting NCT05671276 - Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion Phase 4
Recruiting NCT04502017 - Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion Phase 4