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Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation

NCT02325830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2024-08-05

Study results available
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Summary

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

Conditions

Interventions

DEVICE

Carillon Mitral Contour System

Percutaneous mitral valve repair

Sponsors & Collaborators

  • Menzies Institute for Medical Research

    collaborator OTHER

  • Cardiac Dimensions Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, MD · Cardio Vascular Center

  • David Kaye, MD · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-22
Primary Completion
2018-07-01
Completion
2020-01-08

Countries

  • Australia
  • Czechia
  • France
  • Germany
  • Netherlands
  • New Zealand
  • Poland
  • United Kingdom

Study Locations

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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 NCT02325830 on ClinicalTrials.gov