Improving the safety and effectiveness of a heart procedure for patients with atrial fibrillation
Optimizing Available Data Sources for Post-Marketing Surveillance: Real-World Use of Left Atrial Appendage Occlusion
This study is looking at how safe and effective the Watchman device is for people with atrial fibrillation who can't take blood thinners, using real patient experiences to understand how it helps prevent strokes and bleeding over time.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Yale University NIH-funded |
| Lab location | 1 site (New Haven, United States) |
| Project ID | NIH-10904723 on NIH RePORTER |
What this research studies
This research investigates the long-term safety and effectiveness of the Watchman device, which is used to treat patients with atrial fibrillation who cannot take blood thinners due to bleeding risks. The study utilizes a national registry of patients who have undergone the left atrial appendage occlusion (LAAO) procedure, linking it with Medicare claims data to assess clinical outcomes. By employing advanced statistical methods, the research aims to compare reported events of stroke and bleeding from different data sources, providing insights into real-world patient experiences and outcomes.
Who could benefit from this research
Good fit: Ideal candidates for this research include patients with atrial fibrillation who are not suitable for long-term oral anticoagulation therapy due to high bleeding risk.
Not a fit: Patients with atrial fibrillation who are able to safely use oral anticoagulants may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options and better management of patients with atrial fibrillation, particularly those at high risk for bleeding.
How similar studies have performed: Previous research has shown promise in using registry data and claims data to evaluate cardiovascular interventions, indicating that this approach has potential for success.
Where this research is happening
New Haven, United States
- Yale University — New Haven, United States (Active)
Researchers
- Principal investigator: Faridi, Kamil — Yale University
- Study coordinator: Faridi, Kamil
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.