NCT02592369

CoreValve™ Evolut R™ FORWARD Study

The Medtronic CoreValve™ Evolut R™ FORWARD Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,060 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve™ Evolut R™ System	The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-01
• Completion: 2020-02-06
• First posted: 2015-10-30
• Last updated: 2020-04-30

Locations

54 sites across 21 countries: Australia, Belgium, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom