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Caisson Transcatheter Mitral Valve Replacement (TMVR)

NCT03661398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-01-28

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Conditions

  • Mitral Regurgitation
  • Mitral Valve Disease
  • Mitral Valve Failure
  • Mitral Disease
  • Valve Heart Disease
  • Valve Disease, Heart

Interventions

DEVICE

Transcatheter Mitral Valve Replacement

All eligible patients will be in the treatment arm for treatment with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System. There is no control (comparator) arm for this study.

Sponsors & Collaborators

  • Caisson Interventional LLC

    lead INDUSTRY

Principal Investigators

  • Mat Williams, M.D. · NYU Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2020-08-31
Completion
2025-08-31
FDA Device
Yes

Countries

  • United States

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 NCT03661398 on ClinicalTrials.gov