NCT05565209 Left Atrial Appendage Closure Registry of Henri Mondor Hospital
| NCT ID | NCT05565209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-09-24 |
| Primary Completion | 2026-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-09-24 with a primary completion date of 2026-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Refusal of the patient to participate in this study * Minor patient * Patient not affiliated to the French social security system
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05565209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05565209 currently recruiting?
Yes, NCT05565209 is actively recruiting participants. Contact the research team at emmanuel.teiger@aphp.fr for enrollment information.
Where is the NCT05565209 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT05565209 clinical trial?
NCT05565209 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 250 participants.
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