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Expanded Clinical Study of the Tendyne Mitral Valve System

NCT02321514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2025-07-17

Study results available
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Summary

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

Tendyne Mitral Valve System

Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2020-07-31
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT02321514 on ClinicalTrials.gov