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Updated: Jul 19, 2026
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Potential applicability and utilization of left atrial appendage occlusion devices in patients with atrial
Rebecca Fountain1, David R Holmes, Patricia K Hodgson
1Section of Internal Medicine and Cadiovascular Diseases, Mayo Clinic, Rochester, MN 55905, USA. fountain.rebecca@mayo.edu
Background:
The WATCHMAN left atrial appendage occluder device (Atritech, Inc, Minneapolis, MN) is currently being tested in a Food and Drug Administration-approved clinical trial, the PROTECT AF trial, for patients who are diagnosed with paroxysmal, persistent, or permanent nonvalvular atrial fibrillation. However, rigorous screening and the study design have resulted in the exclusion of a large number of patients. Hence, the purpose of this study was to assess the potential utility of this device among those who were eligible but excluded for trial criteria and the reasons for exclusion.
Methods:
Screening logs from the respective sites participating in the PROTECT AF trial were collected and analyzed for potential utilization outside of a research trial. Only 31 patients were enrolled into the research trail from the screening of 1798 total patients.
Results:
Information from the excluded patients was examined and it was determined that 79% of these patients would be eligible for the device outside the research trial. Twenty-one percent of patients were not able to receive the device because of long-term warfarin need, contraindications to warfarin, unsuitable anatomy as determined by echocardiography, or the inability to take short-term aspirin and clopidogrel for protocol requirements.
Conclusions:
Should a device like the WATCHMAN left atrial appendage occluder be approved, approximately 79% of all patients with atrial fibrillation would be eligible for device placement.
Insights
Most atrial fibrillation patients could use the WATCHMAN device outside clinical trials. This study found 79% of excluded patients were eligible for the left atrial appendage occluder.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Clinical Trials
Background:
- The WATCHMAN left atrial appendage occluder is under FDA-approved investigation in the PROTECT AF trial for nonvalvular atrial fibrillation.
- Strict screening and trial design excluded many potential patients, limiting the device's real-world application assessment.
Purpose of the Study:
- To evaluate the potential use of the WATCHMAN device in patients excluded from the PROTECT AF trial.
- To identify the specific reasons for patient exclusion from the clinical trial.
Main Methods:
- Analysis of screening logs from PROTECT AF trial sites.
- Assessment of 1798 screened patients, with only 31 enrolled in the trial.
Main Results:
- Approximately 79% of excluded patients were deemed eligible for WATCHMAN device implantation outside the trial.
- Key exclusion reasons included warfarin requirements, contraindications, unsuitable anatomy, and inability to comply with dual antiplatelet therapy.
Conclusions:
- If approved, the WATCHMAN left atrial appendage occluder could be suitable for approximately 79% of atrial fibrillation patients.
- This highlights the device's broad potential utility beyond the confines of current clinical trial criteria.
