The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System in Reducing Functional Mitral Regurgitation (FMR) associated with heart failure.

Phase 2

Completed

• Conditions: The CARILLON Mitral Contour System is intented to reduce mitral regurgitation and improve heart failure symptomps; 10046973; 10003184

• Registration Number: NL-OMON44954
• Lead Sponsor: Cardiac Dimensions PTY Ltd

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-16
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

For Main study :;1. Diagnosis of dilated ischemic or non-ischemic cardiomyopathy
2. Functional Mitral Regurgitation: - 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe)
3. NYHA II, III, or IV (refer to Appendix D for NYHA Classification)
4. Six Minute Walk distance of at least 150 meters and no farther than 450 meters
5. Subject meets anatomic screening criteria as determined by angiographic screening at the time of the index procedure to ensure that implant can be sized and placed in accordance with the Instructions for Use
6. Left Ventricular Ejection Fraction <= 50%
NOTE: Subjects with LVEF of 41- 50% can only be included if baseline
NYHA is class III/IV AND MR grade is 3+/4+ (moderately-severe/severe)
7. LV end diastolic dimension (LVEDD) >55mm or LVEDD/BSA >3.0cm/m2
8. Stable heart failure medication regimen for at least three (3) months (refer to Appendix G for definition of stable heart failure regimen)
9. Age >= 18 years old and <= 85 years old
10. The subject has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study
11. Female subjects of child-bearing potential must have a negative serum βHCG test;For Cross-Over registry :
1. Diagnosis of dilated ischemic or non-ischemic cardiomyopathy
2. Functional Mitral Regurgitation: - 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe)
3. NYHA II, III, or IV (refer to Appendix D for NYHA Classification)
4. Subject meets anatomic screening criteria as determined by angiographic screening at the time of the index procedure to ensure that implant can be sized and placed in accordance with the Instructions for Use
5. Left Ventricular Ejection Fraction <= 50%
NOTE: Subjects with LVEF of 41- 50% can only be included if baseline
NYHA is class III/IV AND MR grade is 3+/4+ (moderately-severe/severe)
6. LV end diastolic dimension (LVEDD) >55mm or LVEDD/BSA >3.0cm/m2
7. The subject has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study
8. Female subjects of child-bearing potential must have a negative serum βHCG test

Exclusion Criteria

Main study :
1. Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
2. Hospitalization in the past 30 days for coronary angioplasty or stent placement
3. Subjects expected to require any cardiac surgery, including surgery for coronary artery disease (unprotected left main stenosis greater than or equal to 50% or, greater than or equal to 70% stenosis in at least three (3) epicardial coronary arteries in the absence of prior bypass surgery), or for pulmonic, aortic, or tricuspid valve disease within one (1) year
4. Subjects with echocardiographic documentation of non-compaction cardiomyopathy with associated hypercontractility of the cardiac structures supporting the mitral annulus
5. Subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
6. Recipient of intravenous positive-inotrope infusion or intra- aortic balloon pump support within the past 30 days
7. Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or mitral annuloplasty ring
8. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV), or anticipated need for cardiac resynchronization therapy (CRT) within twelve (12) months
9. Presence of a coronary artery stent under the CS / GCV in the implant target zone
10. 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)
11. Presence of severe mitral annular calcification
12. Presence of left atrial appendage (LAA) clot. Patients with a current/ongoing (documented within the last 12 months) history of atrial fibrillation must undergo a trans-esophageal echo prior to the procedure to rule-out left atrial appendage clot to minimize the risk of thromboembolism
caused by the tissue plication
13. Cerebral vascular event within the past three (3) months
14. Presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dL (194.5 µmol/L) OR estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
15. Allergy to contrast dye that cannot be pre-medicated
16. Inability to undertake a six-minute walk test due to physical restrictions/limitations
17. Chronic severe pathology limiting survival to less than 12-months
18. Anticipated need of left ventricular assist device within twelve (12) months
19. Currently participating in an investigational study that clinically interferes
with the current study endpoints.;Cross-over registry:
1. Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
2. Hospitalization in the past 30 days for coronary angioplasty or stent placement
3. Subjects with echocardiographic documentation of non-compaction cardiomyopathy with associated hypercontractility of the cardiac structures supporting the mitral annulus
4. Subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
5. Recipient of intravenous positive-inotrope infusion or intra- aortic balloon pump support within the past 30 days
6. Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or mitral annuloplasty ring
7. Pre-existing device (e.g., pacing lead)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is to demonstrate a statistically significant<br /><br>improvement in regurgitant volume associated with the CARILLON device at twelve<br /><br>(12) months, relative to the Control population.</p><br>