Brief Title
CoreValve™ Evolut R™ FORWARD Study
Official Title
The Medtronic CoreValve™ Evolut R™ FORWARD Study
Brief Summary
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.
Detailed 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.
Study Type
Observational
Primary Outcome
All-cause mortality rate
Secondary Outcome
Device success according to VARC2
Condition
Aortic Valve Stenosis
Intervention
Medtronic CoreValve™ Evolut R™ 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
1060
Start Date
January 2016
Completion Date
February 6, 2020
Primary Completion Date
February 2017
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Eberhard Grube, Prof. Dr., ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02592369
Organization ID
Evolut R™ FORWARD Study
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Study Sponsor
Eberhard Grube, Prof. Dr., Principal Investigator, University Hospital, Bonn
Verification Date
April 2020