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Updated: May 6, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Long-Term Follow-Up of Left Atrial Appendage Exclusion: Results of the V-CLIP Multi-Center Post-Market Study
Elias Zias1, Katherine G Phillips1, Marc Gerdisch2
1Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA.
Insights
The V-shape AtriClip device achieved complete left atrial appendage exclusion (LAAE) in 97% of cardiac surgery patients. This epicardial device demonstrated safety and effectiveness for preventing stroke risk over 12 months.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Innovation
Background:
- Atrial fibrillation post-cardiac surgery increases thromboembolic stroke risk, often linked to left atrial appendage (LAA) thrombus.
- Complete surgical LAA exclusion (LAAE) is crucial to prevent thrombus formation.
- Epicardial devices offer a minimally invasive approach to LAAE.
Purpose of the Study:
- To evaluate the long-term safety and performance of the epicardial V-shape AtriClip device for LAAE.
- To assess the rate of complete LAAE and device-related adverse events over 12 months.
Main Methods:
- A prospective, multi-center, post-market study (NCT05101993) involving 155 cardiac surgery patients.
- Patients received V-shape AtriClip devices and underwent 12-month follow-up with LAA imaging.
- Primary endpoints included complete LAAE and device/procedure-related serious adverse events (SAEs) within 30 days.
Main Results:
- Complete LAAE was achieved in 97% of patients (intent-to-treat population).
- The primary safety endpoint was met, with 100% of patients free from pre-defined SAEs within 30 days.
- One device-related SAE occurred but resolved intraprocedurally.
Conclusions:
- The V-shape AtriClip device demonstrated safe and effective LAAE in cardiac surgery patients.
- The device shows sustained performance and safety through 12 months of follow-up.
- This study supports the use of epicardial V-shape AtriClip for LAAE to mitigate stroke risk.
Abstract:
Background: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. Methods: This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients ≥18 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. Results: Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; p = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; p < 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up.
