Registry for patients receiving heart valve surgery products
Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
This study is tracking how well heart valve repair and replacement products work and are tolerated by patients who have had these surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Sex | All |
| Sponsor | Medtronic Cardiac Surgery Industry-sponsored |
| Locations | 26 sites (Marietta, Georgia and 25 other locations) |
| Trial ID | NCT04073420 on ClinicalTrials.gov |
What this trial studies
This registry is designed to monitor the safety and effectiveness of surgical heart valve repair and replacement products in patients. It collects data from individuals who are either currently receiving or have received these products, ensuring ongoing post-market surveillance. The registry aims to gather comprehensive information that can help improve patient outcomes and inform future medical practices related to heart valve treatments.
Who should consider this trial
Good fit: Ideal candidates include patients who are receiving or are intended to receive surgical heart valve repair or replacement products.
Not a fit: Patients who are inaccessible for follow-up or are involved in other investigational studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of heart valve surgery outcomes and improve patient care.
How similar studies have performed: Other post-market surveillance registries have shown success in improving patient outcomes and safety monitoring for medical devices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2. Patient has or is intended to receive or be treated with an eligible product 3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment Exclusion Criteria: 1. Patient who is, or is expected to be, inaccessible for follow-up 2. Patient prohibited from participation by local law 3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results
Where this trial is running
Marietta, Georgia and 25 other locations
- WellStar Kennestone Hospital — Marietta, Georgia, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Mount Sinai Medical Center — New York, New York, United States (Recruiting)
- Saint Francis Hospital — Roslyn, New York, United States (Withdrawn)
- Saint Josephs Hospital Health Center — Syracuse, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University Hospitals Cleveland — Cleveland, Ohio, United States (Recruiting)
- University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
- Baylor St. Luke's Medical Center — Houston, Texas, United States (Recruiting)
- The Heart Hospital Plano — Plano, Texas, United States (Recruiting)
- Inova — Falls Church, Virginia, United States (Recruiting)
- Allgemeines Krankenhaus - Universitätskliniken Wien — Vienna, Austria (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Hôpital Haut-Lévêque - CHU de Bordeaux — Pessac, France (Recruiting)
- Schüchtermann-Klinik — Bad Rothenfelde, Germany (Recruiting)
- Herzzentrum Dresden GmbH Universitätsklinik — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Albertinen-Herz- und Gefäßzentrum — Hamburg, Germany (Recruiting)
- Herzzentrum Leipzig — Leipzig, Germany (Recruiting)
- Deutsches Herzzentrum München Klinik an der TU München — München, Germany (Recruiting)
- Onassis Cardiac Surgery Center — Athens, Greece (Recruiting)
- Ospedale Pasquinucci Massa — Massa, Italy (Recruiting)
- IRCCS Policlinico — San Donato, Italy (Recruiting)
- Leids Universitair Medisch Centrum — Leiden, Netherlands (Recruiting)
- Hospital Regional Universitario Carlos Haya Málaga - Hospital General — Málaga, Spain (Recruiting)
- Inselspital - Universitätsspital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lisa Slusser
- Email: rs.hvtpmcfregistry@medtronic.com
- Phone: 1-800-328-2518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.