No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Cardiac Dimensions, Inc. · Industry
Who this trial is looking for
This trial is looking for individuals with heart failure and a specific type of mitral valve problem. Participants will be randomly assigned to receive either the treatment or a control and will need to attend follow-up visits.
Are You a Good Fit for This Trial?
You may be able to join if
I have heart failure with mild to moderate mitral regurgitation.
I have a six-minute walk distance of at least 100 meters.
I am at least 18 years old.
I have a left ventricular ejection fraction of 50% or less.
I have had heart failure issues within the past year.
I am currently taking heart failure medications as prescribed.
The doctor can place the Carillon implant in me.
You may not be able to join if
I have a mechanical or bio-prosthetic mitral valve.
I have severe issues with my mitral valve.
I have severe tricuspid regurgitation.
I have severe aortic stenosis.
I am expected to need cardiac surgery in the next year.
I have other serious medical conditions that could shorten my life.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
2. NYHA II, III, or IV
3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
4. Left Ventricular Ejection Fraction ≤ 50%
5. LVEDD:
* ≥ 55 mm (women)
* ≥ 57 mm …
Inclusion Criteria:
1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
2. NYHA II, III, or IV
3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
4. Left Ventricular Ejection Fraction ≤ 50%
5. LVEDD:
* ≥ 55 mm (women)
* ≥ 57 mm (men)
6. LVESD ≤ 75 mm
7. Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
9. Age ≥ 18 years old
10. Carillon implant can be sized and placed in accordance with the IFU
11. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent
Exclusion Criteria:
1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
4. Severe mitral annular calcification
5. Severe aortic stenosis
6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study
* An entire list of eligibility is available in the clinical investigational plan
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