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

Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding; Left Atrial Appendage Thrombosis; Cardioembolic Stroke

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of left atrial appendage occlusion (LAAO) with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratoriesleft atrial.	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)	At 8 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): May 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Left atrial appendage occlusion · WATCHMAN · AMPLATZER Amulet · Atrial fbrillation · Stroke · Echocardiography · Cardiac computed tomography angiography
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation; Thrombosis; Embolic Stroke
• Other Study ID Numbers: 29BRC23.0255 - CLAPOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No