# Optimizing Available Data Sources for Post-Marketing Surveillance: Real-World Use of Left Atrial Appendage Occlusion

> **NIH NIH K23** · YALE UNIVERSITY · 2024 · $192,038

## Abstract

PROJECT SUMMARY/ABSTRACT
Atrial fibrillation is a major cause of ischemic stroke and stroke-associated mortality worldwide. Though risk of
ischemic stroke in patients with atrial fibrillation is reduced with oral anticoagulation (OAC), many are not
suitable candidates for long-term OAC due to high bleeding risk. To help treat such patients, transcatheter left
atrial appendage occlusion (LAAO) with the Watchman device was developed and approved as an alternative
to OAC. However, efficient methods for evaluating clinical outcomes associated the Watchman device and
other novel cardiovascular technologies are needed for long-term surveillance after regulatory approval. In this
mentored patient-oriented career development award, Dr. Kamil Faridi will use a national registry of LAAO
procedures linked to Medicare claims data to evaluate how different data sources and innovative statistical
approaches can be utilized for evaluating the long-term safety and effectiveness of the Watchman device in
real-world practice. In Aim 1, he will use traditional and advanced statistical methods to compare ischemic
stroke and bleeding events identified with administrative claims data to site-reported events in a national
registry of patients who undergo transcatheter LAAO. In Aim 2, he will use linked pharmacy claims data to
evaluate registry-reported OAC use and compare outcomes between LAAO patients and medically managed
patients with atrial fibrillation in real-world practice. To supplement quantitative strategies for post-marketing
surveillance, in Aim 3 he will use qualitative methods to explore patient-reported perspectives and quality of life
among patients referred for transcatheter LAAO. Accomplishing these research aims will lay the groundwork
for future studies examining real-world surveillance of other cardiovascular therapies and other clinically
important outcomes. This project will be led by Dr. Kamil Faridi, an early career investigator, cardiologist, and
faculty member at the Yale School of Medicine with a track record of success in the field of cardiovascular
outcomes research. During this 5-year program, Dr. Faridi will pursue additional training in machine learning,
pharmacoepidemiology, comparative effectiveness and qualitative methods applied to patient-oriented
research. This will be accomplished with a comprehensive career development program designed to provide
Dr. Faridi with the skills needed to become a successful clinical researcher in cardiovascular medicine. His
long-term career goal is to become an independent investigator with specific expertise in the areas of post-
marketing surveillance and real-world data utilization for novel cardiovascular therapies, with the ultimate aim
of improving patient care. Over the course of the research and training program, Dr. Faridi will be guided by an
exceptional mentorship team and advisory committee consisting of established clinical investigators with
expertise in cardiovascular medicine, outcom...

## Key facts

- **NIH application ID:** 10904723
- **Project number:** 5K23HL161424-03
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Kamil Faridi
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $192,038
- **Award type:** 5
- **Project period:** 2022-09-09 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10904723

## Citation

> US National Institutes of Health, RePORTER application 10904723, Optimizing Available Data Sources for Post-Marketing Surveillance: Real-World Use of Left Atrial Appendage Occlusion (5K23HL161424-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10904723. Licensed CC0.

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