MedTrace Logo

Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

NCT01437098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-02-15

Study results available
· View outcomes & findings →

Summary

The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

MDT-2111 CoreValve for TAVI

CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-30
Completion
2018-11-27

Countries

  • Japan

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 NCT01437098 on ClinicalTrials.gov