Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)

Active, not recruiting

• Conditions: Atrial Fibrillation; Cardioembolic Stroke; Left Atrial Appendage Thrombosis; Anticoagulant-induced Bleeding

• Registration Number: NCT06232278
• Lead Sponsor: University Hospital, Brest

Brief Summary

Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score.

However, serious bleeding complications may definitively contraindicate the use of anticoagulants.

For those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events.

In the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories.

This retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Study Start: 2024-02-01
• Primary Completion: 2024-05-31
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Major
• Non opposition
• All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023

Exclusion Criteria

• Minor
• Patients under tutorship or curatorship
• Formulated opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of left atrial appendage occlusion with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories	From 15 February 2024 to 15 April 2024	Effectiveness is assessed by a composit endpoint that combines transient ischemic attack (TIA)/stroke, systemic embolism, cardiovascular mortality or All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Safety of left atrial appendage occlusion (LAAO) with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratoriesleft atrial.	At 8 weeks	The safety is defined as occurrence of events related to the device (device embolization, the presence of visible thrombus on the surface of the device, significant peri-device leak) and events related to the procedure (serious pericardial effusion requiring drainage, intracranial or gastrointestinal bleeding or other major bleeding requiring transfusion)

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France