Status:
COMPLETED
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Brief Summary
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation p...
Detailed Description
Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.
Eligibility Criteria
Inclusion
- Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
- High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
- Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
- Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
- Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.
Exclusion
- Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
- Preexisting mechanical heart valve in aortic position
- Ongoing sepsis, including active endocarditis
- Anatomically not suitable for the Evolut™ PRO system
- Estimated life expectancy of less than 1 year
- Participating in another trial that may influence the outcome of this study
- Need for emergency surgery for any reason
- Inability to understand and respond to the quality of life questionnaire
Key Trial Info
Start Date :
February 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT03417011
Start Date
February 26 2018
End Date
February 26 2024
Last Update
September 9 2025
Active Locations (39)
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1
LKH - Universitätsklinikum
Graz, Austria
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
3
CHU de Liège - Hôpital du Sart Tilman
Liège, Belgium
4
Rigshospitalet
Copenhagen, Denmark