ClinicalTrials.Veeva

Menu

FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Covidien logo

Covidien

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)

Study type

Observational

Funder types

Industry

Identifiers

NCT03417011
MDT17050EVR003

Details and patient eligibility

About

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.

Full 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.

Enrollment

638 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

39

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems