Improving safety monitoring for heart devices by understanding learning effects
Incorporating Learning Effects into Medical Device Active Safety Surveillance Methods
['FUNDING_R01'] · VANDERBILT UNIVERSITY MEDICAL CENTER · NIH-10570892
This study is looking at how using heart devices can be made safer by understanding how experience with them affects patient outcomes, so we can help doctors and manufacturers improve these devices and make sure the right patients get the best care.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | VANDERBILT UNIVERSITY MEDICAL CENTER (nih funded) |
| Locations | 1 site (NASHVILLE, UNITED STATES) |
| Trial ID | NIH-10570892 on ClinicalTrials.gov |
What this research studies
This research focuses on enhancing the safety of implantable cardiovascular devices by investigating how learning effects influence their performance. It aims to develop a method for active safety surveillance that goes beyond traditional reporting, allowing for real-time feedback on device use and outcomes. By quantifying how experience with these devices affects patient outcomes, the research seeks to identify which patients benefit most from specific devices and provide insights for manufacturers to improve their designs. This approach could also highlight training needs for healthcare providers to optimize device usage.
Who could benefit from this research
Good fit: Ideal candidates for this research are individuals with acute or chronic cardiovascular conditions who may require implantable medical devices.
Not a fit: Patients who do not have cardiovascular conditions or do not require implantable devices may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer and more effective use of heart devices, ultimately improving patient outcomes.
How similar studies have performed: Previous research has shown that incorporating learning effects into medical device monitoring can lead to significant improvements in patient safety and device performance.
Where this research is happening
NASHVILLE, UNITED STATES
- VANDERBILT UNIVERSITY MEDICAL CENTER — NASHVILLE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: MATHENY, MICHAEL E. — VANDERBILT UNIVERSITY MEDICAL CENTER
- Study coordinator: MATHENY, MICHAEL E.
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.