FORWARD PRO Study
- Conditions
- Aortic valve stenosis10046973
- Registration Number
- NL-OMON46344
- Lead Sponsor
- Medtronic Trading NL BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Patients must meet ALL of the following inclusion criteria:
1.Symptomatic native aortic valve stenosis or a stenosed,
insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
2.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)
3.Acceptable candidate for treatment with the Evolut* PRO system in conformity with the local regulations
4.Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
5.Written informed consent obtained without assistance from a legal representative prior to enrollment in the study
Patients are NOT eligible for study participation if they meet ANY of the following exclusion criteria:;1.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
2.Preexisting mechanical heart valve in aortic position
3.Ongoing sepsis, including active endocarditis
4.Anatomically not suitable for the Evolut* PRO system
5.Estimated life expectancy of less than 1 year
6.Participating in another trial that may influence the outcome of this study
7.Need for emergency surgery for any reason
8.Inability to understand and respond to the quality of life questionnaire
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The all-cause mortality rate at 30 days post procedure meets a performance goal<br /><br>of 5.5%.</p><br>
- Secondary Outcome Measures
Name Time Method <p>•The percentage of subjects graded as none or trace total aortic regurgitation<br /><br>at discharge is greater than a prespecified performance goal of 67.1%.<br /><br>•VARC-2 safety and efficacy endpoints as well as hemodynamic performance<br /><br>metrics (incl. mean gradient, effective orifice area and prosthetic<br /><br>regurgitation).</p><br>