Evaluation of a new valved graft for heart surgery
Official title: Valved Graft Post-Market Clinical Follow-up Study
Run by Abbott Medical Devices · NCT04754217 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Status | Recruiting |
| Started | July 13, 2021 |
| Main results expected | July 2029 |
| Study ends | September 2029 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT04754217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients scheduled for cardiac surgery involving the implantation of a valved graft for valve replacement.
✕Probably not a fit
Patients who are intolerant to anticoagulation therapy or have active endocarditis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies involving similar valved grafts have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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University of Michigan
Ann Arbor, Michigan, United States Recruiting -
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
Show 19 more locations
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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 -
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland 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 -
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States Withdrawn -
Mission Health & Hospitals
Asheville, North Carolina, United States Withdrawn -
Wojewodzki Szpital Zespolony w Kielcach
Kielce, Poland Withdrawn -
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, Poland Active not recruiting
Study contacts
- Study coordinator: Paolo Amato
- Email: paolo.amato@abbott.com
- Phone: +39 335 61 40 573
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pregnancy-Related Aortic Dissection in China
This study looks at cases of aortic dissection that occur during pregnancy or shortly after, to understand outcomes for mothers and babies.
-
KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement
This study tests how the KONECT RESILIA aortic valved conduit performs in adults needing aortic valve and ascending aorta replacement.
-
Savvywire versus standard LV guidewires during transfemoral TAVI
For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.
-
EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis
This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.
-
Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
-
Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults
This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.