Left Atrial Appendage Closure Registry of Henri Mondor Hospital

NCT05565209 | Recruiting DMC

• 1 other identifier: APHP220614
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records. Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Left atrial appendage closure, stroke, anticoagulation, bleeding

Outcome Measures

Primary Outcomes (1)

• Frequency of thrombo-embolic events

  The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.

  60months of follow-up after the procedure

Secondary Outcomes (19)

• Efficacy of the procedure

  One hour after the end of the procedure

• Occlusion of the left atrial appendage

  3 months

• residual peri-device leak

  3 months

• Percentage of ischemic stroke

  1 and 5 years after the procedure

• Percentage of transient ischemic attack (TIA)

  1 and 5 years after the procedure

Interventions

SA brief descriptive name used to refer to the intervention(s) studied OTHER

Details that can be made public about the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A description of the population from which the groups or cohorts will be selected

You may qualify if:

• Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)

You may not qualify if:

• Refusal of the patient to participate in this study
• Minor patient
• Patient not affiliated to the French social security system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Emmanuel Teiger, MD, PhD

CONTACT

00 33 1 49 81 22 51; emmanuel.teiger@aphp.fr

Philippe Le Corvoisier, MD, PhD

CONTACT

+33149813790; philippe.lecorvoisier@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 4, 2022
• Study Start: September 24, 2022
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 14, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)