Evaluation of a new valved graft for heart surgery
Valved Graft Post-Market Clinical Follow-up Study
Abbott Medical Devices · NCT04754217
This study is testing a new heart valve graft in patients having heart surgery to see how well it works and if it's safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices (industry) |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Trial ID | NCT04754217 on ClinicalTrials.gov |
What this trial studies
This observational study involves multiple centers globally and focuses on patients undergoing cardiac surgery that includes the implantation of an Abbott Valved Graft device. Participants will be monitored post-surgery to assess the performance and outcomes associated with the graft. The study aims to gather data on the effectiveness and safety of the valved graft in treating conditions such as aortic valve disease and aortic dissection. It is a non-randomized, prospective trial that seeks to provide insights into the long-term benefits of this intervention.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for cardiac surgery involving the implantation of a valved graft for valve replacement.
Not a fit: Patients who are intolerant to anticoagulation therapy or have active endocarditis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for patients with aortic valve disease and related conditions.
How similar studies have performed: Other studies involving similar valved grafts have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement Exclusion Criteria: * anticoagulation therapy intolerant * active endocarditis * anatomical or medical, surgical, psychological or social contraindications
Where this trial is running
Birmingham, Alabama and 24 other locations
- University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States (WITHDRAWN)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Mission Health & Hospitals — Asheville, North Carolina, United States (WITHDRAWN)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Klinik Floridsdorf — Vienna, Austria (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- CHU de Besancon - Jean Minjoz — Besançon, France (RECRUITING)
- CHRU Lille — Lille, France (RECRUITING)
- Groupe Hospitalier Bichat - Claude Bernard — Paris, France (RECRUITING)
- Herz-und Diabetes Zentrum NRW — Bad Oeynhausen, Germany (RECRUITING)
- Deutsches Herzzentrum Berlin — Berlin, Germany (RECRUITING)
- Klinikum Links der Weser — Bremen, Germany (RECRUITING)
- Medizinische Hochschule Hannover — Hanover, Germany (RECRUITING)
- Onassis Cardiac Surgery Center — Athens, Greece (RECRUITING)
- Policlinico S.Orsola-Malpighi — Bologna, Italy (RECRUITING)
- Ospedale San Raffaele — Milan, Italy (RECRUITING)
- Policlinico San Donato — San Donato Milanese, Italy (RECRUITING)
- Wojewodzki Szpital Zespolony w Kielcach — Kielce, Poland (WITHDRAWN)
- Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow, Poland (RECRUITING)
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz, Poland (ACTIVE_NOT_RECRUITING)
- The Cardinal Stefan Wyszynski Institute of Cardiology — Warsaw, Poland (RECRUITING)
- Hospital Universitario del Vinalopó — Elche, Spain (RECRUITING)
- Hospital Universitario Son Espases — Palma de Mallorca, Spain (RECRUITING)
- James Cook University Hospital — Middlesbrough, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Paolo Amato
- Email: paolo.amato@abbott.com
- Phone: +39 335 61 40 573
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.
Conditions: Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection, Aortic Root Replacement, Ascending Aorta Replacement, Valved Graft, CAVGJ, VAVGJ