Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT06465706
Brief Summary:
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
Detailed Description:
The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are:
Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period.
Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.
Study:
NCT06465706
Study Brief:
Protocol Section:
NCT06465706