An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation

NCT04529928 | Terminated

• 1 other identifier: CVP-3473-01
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 2

Brief Summary

The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)

Conditions

Functional Mitral Regurgitation; Atrial Fibrillation; Atrial Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline

  6 Months

Study Arms (1)

Implanted

EXPERIMENTAL

Subjects successfully implanted with the Carillon Mitral Contour System

Device: Carillon Mitral Contour System

Interventions

Carillon Mitral Contour System DEVICE

Eligible subjects will be implanted with the Carillon Device, utilizing the Carillon Mitral Contour System. The device is a permanent implant in the coronary sinus/great cardiac vein, designed to cinch the mitral annulus. The implant procedure is minimally invasive, conducted via catheter placement.

Also known as: Carillon, Carillon Device, Carillon Implant

Implanted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate-to-severe non-primary Mitral Regurgitation (as assessed by qualitative, semi-quantitative and/or quantitative echocardiographic assessment in the setting of all of the following:
• a. Severe left atrial (LA) dilatation as defined by at least two (2) of the following: i. LA area ≥ 41cm2 ii. Indexed LA volume \> 48mL/m2 iii. LA diameter ≥ 52 mm for men and ≥ 46 mm for women b. Preserved left ventricular contractility (Left Ventricular Ejection Fraction ≥50% by Simpson's biplane technique) c. No more than mild left ventricular dilatation as defined by: i. LV diastolic volume/BSA (mL/m2) \<90 mL/m2 for men and \<71 mL/m2 for women ii. LV systolic volume/BSA (mL/m2) \<39 mL/m2 for men and \<33 mL/m2 for women
• New York Heart Association (NYHA) Class II, III or ambulatory IV heart failure
• Stable heart failure medication regimen for at least 30 days prior to index procedure including antihypertensives and/or diuretics to achieve controlled BP (\< 140 mmHg systolic) and adequate heart rate control (\<100 bpm resting HR)
• Patient deemed appropriate candidate for transcatheter mitral valve repair by the local multidisciplinary heart team
• 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
• Female subjects of child-bearing potential must have a negative serum BHCG test
• Age ≥ 18 years old
• The subject has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study

You may not qualify if:

• Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
• Evidence of transient ischemic attack or stroke within three (3) months prior to intervention
• Percutaneous coronary intervention in the last 30 days
• Subjects expected to require any cardiac surgery, including surgery for coronary artery disease or for pulmonic, aortic, or tricuspid valve disease within one (1) year
• Subjects expected to require any percutaneous coronary intervention within 30 days of the index procedure.
• 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
• Presence of a coronary artery stent under the CS / GCV in the implant target zone
• Presence of left atrial appendage (LAA) clot.
• 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
• Poorly controlled atrial fibrillation or flutter, with poor ventricular rate control (\> 100 bpm resting HR), or other poorly controlled symptomatic brady- or tachy-arrhythmias
• Uncontrolled hypertension (BP \> 180 mmHg systolic and/or \>105 mmHg diastolic) or hypotension (BP \< 90 mmHg systolic) at baseline
• Presence of severe mitral annular calcification
• Prior mitral valve surgery
• Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or mitral annuloplasty ring
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

Sponsors & Collaborators

• Cardiac Dimensions Pty Ltd: lead

Study Sites (2)

Royal Prince Alfred

Sydney, New South Wales, Australia

Location

European Interbalkan Medical Center

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: October 19, 2020
• Primary Completion: September 22, 2021
• Study Completion: December 22, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); AU (1)