CLIP-IT Post-Market Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Penditure™ Left Atrial Appendage (LAA) Exclusion System: Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Study summary
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Eligibility
Primary outcome measure(s)
- Rate of Successful Exclusion of the Left Atrial Appendage (LAA) From the Heart — 3 months post procedure
The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan. - Rate of Device-related Serious Adverse Cardiac Events — 30 days post procedure
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Emory Saint Joseph's Hospital | Atlanta | Georgia | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| Ascension St. Vincent Heart Center | Carmel | Indiana | |
| University of Michigan Health System | Ann Arbor | Michigan | |
| Corewell Health | Grand Rapids | Michigan | |
| Mayo Clinic Saint Marys Campus | Rochester | Minnesota | |
| Barnes Jewish Hospital | St Louis | Missouri | |
| Saint Joseph's Hospital Health Center | Syracuse | New York | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| ProMedica Toledo Hospital | Toledo | Ohio | |
| UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | |
| Houston Methodist Hospital | Houston | Texas | |
| Swedish Medical Center Cherry Hill | Seattle | Washington |
More Medtronic Cardiac Surgery trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06203054 on ClinicalTrials.gov ↗ ← All trials in the USA