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Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation

NCT05040451 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-10-07

No results posted yet for this study

Summary

Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation. This will be primarily evaluated by standard of care exercise testing and echocardiography. The purpose is to evaluate HFrEF CHF patients that may have mild to moderate-severe MR at rest but aggravated upon activity.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

Carillon Mitral Contour System

The Carillon Mitral Contour System (XE2) consists of the following components: * An implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV) * A delivery system which consists of a custom 9F delivery catheter and a handle assembly.

Sponsors & Collaborators

  • Cardiac Dimensions Pty Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-09-30
Completion
2023-09-30

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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 NCT05040451 on ClinicalTrials.gov