Carillon Mitral Contour System for Heart Failure

Community Healthcare System, Munster, IN
Heart Failure+5 More ConditionsCarillon Mitral Contour System - Device
All Sexes

Study Summary

This trial will compare the safety and effectiveness of a new mitral valve device to treat heart failure with mild regurgitation to current standard care.

Eligible Conditions
  • Heart Failure
  • Heart Disease
  • Mitral Regurgitation
  • Cardiovascular Disease
  • Mitral Valve Regurgitation
  • Heart Valve Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 12 months of follow-up, and any available data up to 24 months

12 months
Primary Efficacy Objective 1 - Hierarchical Clinical Composite
Primary Safety Objective - Freedom from Major Adverse Events
Secondary Efficacy Objective 1- Regurgitant Volume
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume
Secondary Efficacy Objective 2 - HFH Days
Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume
Secondary Efficacy Objective 4 - Change in 6 Minute Walk Distance
Secondary Efficacy Objective 5 - Change in KCCQ
Secondary Efficacy Objective 6 - Change in NYHA Classification
Month 24
Secondary Efficacy Objective 7 - Percent days lost due to HFH or CV death
Secondary Efficacy Objective 8 - Incidence of alternative therapy and all-cause mortality
Secondary Efficacy Objective 9 - Total number of HFH
Day 30
Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control Group
1 of 2
Intervention Group
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Carillon Mitral Contour System · No Placebo Group · N/A

Intervention GroupExperimental Group · 2 Interventions: Carillon Mitral Contour System, Guideline Directed Heart Failure Medication · Intervention Types: Device, Other
Control Group
ActiveComparator Group · 1 Intervention: Guideline Directed Heart Failure Medication · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months of follow-up, and any available data up to 24 months

Who is running the clinical trial?

Cardiac Dimensions, Inc.Lead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
Samir Kapadia, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
3,713 Total Patients Enrolled
Randall Starling, MDPrincipal InvestigatorThe Cleveland Clinic
4 Previous Clinical Trials
726 Total Patients Enrolled
2 Trials studying Heart Failure
101 Patients Enrolled for Heart Failure
Marc Gillinov, MDPrincipal InvestigatorThe Cleveland Clinic
5 Previous Clinical Trials
3,430 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a heart condition called cardiomyopathy, either caused by lack of blood flow or not caused by lack of blood flow.
You are able to walk between 150 and 450 meters in six minutes.

Frequently Asked Questions

What is the estimated number of participants in this trial?

"Cardiac Dimensions, Inc. is in search of 300 individuals that fit the trial's entrance requirements to conduct this study at Banner University Tucson and University of California- San Francisco." - Anonymous Online Contributor

Unverified Answer

How many venues are participating in the experimental protocol?

"This clinical trial is available in 40 various medical locations, including Banner University Tuscon (Tuscon), University of California- San Francisco (San Francisco) and UCLA Medical Center (Los Angeles)." - Anonymous Online Contributor

Unverified Answer

Are there any remaining opportunities for participants to join this research?

"The details posted on suggest that this trial is still recruiting participants; it was first published on the 1st of January 2018, with its most recent update being issued in October 2021." - Anonymous Online Contributor

Unverified Answer

What is the objective of this experiment?

"This trial has been designed to measure the hierarchical clinical composite as its primary efficacy objective. A number of secondary outcomes have also been detailed, including changes in NYHA classification, regurgitant volume, and left ventricular end-diastolic volume over a 12 month time frame." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.