CoreValve™ Evolut R™ FORWARD Study

Covidien

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Medtronic CoreValve™ Evolut R™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT02592369

Evolut R™ FORWARD Study

Details and patient eligibility

About

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Full description

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Enrollment: 1,060 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

• Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context

• Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

  • Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR
  • Documented heart team agreement of risk for AVR due to frailty or comorbidities.

• Geographically stable and willing to return to the implanting site for all follow-up visits

• Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial

• The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

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 R system
• Estimated life expectancy of less than 1 year
• Participating in another trial that may influence the outcome of this trial
• Need for emergency surgery for any reason

Trial design