Aortic Valve Disease Clinical Trial
Official title:
Valved Graft Post-Market Clinical Follow-up Study
| NCT number | NCT04754217 |
| Other study ID # | ABT-CIP-10386 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 13, 2021 |
| Est. completion date | September 2029 |
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
| Status | Recruiting |
| Enrollment | 260 |
| Est. completion date | September 2029 |
| Est. primary completion date | July 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Klinik Floridsdorf | Vienna | |
| Denmark | Rigshospitalet | Copenhagen | |
| France | CHU de Besancon - Jean Minjoz | Besançon | |
| France | CHRU Lille | Lille | |
| France | Groupe Hospitalier Bichat - Claude Bernard | Paris | |
| Germany | Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | |
| Germany | Deutsches Herzzentrum Berlin | Berlin | |
| Germany | Klinikum Links der Weser | Bremen | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Greece | Onassis Cardiac Surgery Center | Athens | |
| Italy | Policlinico S.Orsola-Malpighi | Bologna | |
| Italy | Ospedale San Raffaele | Milan | |
| Italy | Policlinico San Donato | San Donato Milanese | |
| Poland | Wojewodzki Szpital Zespolony w Kielcach | Kielce | |
| Poland | Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | |
| Poland | Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lódz | |
| Poland | The Cardinal Stefan Wyszynski Institute of Cardiology | Warsaw | |
| Spain | Hospital Universitario del Vinalopó | Elche | |
| Spain | Hospital Universitario Son Espases | Palma De Mallorca | |
| United Kingdom | James Cook University Hospital | Middlesbrough | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Austria, Denmark, France, Germany, Greece, Italy, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | annualized event rate of all-cause mortality | Primary Safety Endpoint | 5 Years | |
| Primary | annualized event rate of reintervention | Primary Effectiveness Endpoint | 5 Years |
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