Brief Title
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Official Title
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
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 purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
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.
Study Type
Observational
Primary Outcome
All-cause mortality
Secondary Outcome
Total AR
Condition
Aortic Valve Stenosis
Intervention
Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
638
Start Date
February 26, 2018
Completion Date
September 30, 2024
Primary Completion Date
March 6, 2019
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03417011
Organization ID
MDT17050EVR003
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Study Sponsor
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Verification Date
October 2020