MedTrace Logo

Medtronic CoreValve REDO Study

NCT01051310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-01-31

Study results available
· View outcomes & findings →

Summary

The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure.

These objectives will be achieved through the following endpoints:

* Primary safety endpoint - Composite of Major Adverse Events
* Primary performance endpoint - Technical and procedural success at discharge

Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic CoreValve System

Transcatheter Aortic Valve

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • E. Grube, Prof. Dr. · Helios Heart Center Siegburg, Germany

  • G. Schuler, Prof. Dr. · Universitat Leipzig Herzzentrum, Germany

  • R. Lange, Prof. Dr. · Deutsches Herzzentrum Munich, Germany

  • P. de Jaegere, Dr. · Erasmus MC Rotterdam, Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051310 on ClinicalTrials.gov