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Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

NCT03539458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-11-18

Study results available
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Summary

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Conditions

  • Mitral Regurgitation
  • Mitral Insufficiency
  • Mitral Annular Calcification
  • Mitral Annulus Calcification
  • Cardiovascular Diseases
  • Valve Heart Disease
  • Heart Valve Diseases
  • Heart Valve Calcification
  • Mitral Valve Disease

Interventions

DEVICE

Tendyne Mitral Valve System

Mitral valve replacement

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Paul Sorajja, MD · Minneapolis Heart Institute - Abbott Northwestern Hospital

  • Vinod Thourani, MD · Piedmont Heart Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-11-29
Completion
2024-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03539458 on ClinicalTrials.gov