NCT02209298

CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 202 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

Detailed description

To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	CoreValve Transcatheter Valve	Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-11-01
• Completion: 2018-12-03
• First posted: 2014-08-05
• Last updated: 2019-04-16

Locations

25 sites across 4 countries: France, Germany, Israel, Italy