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

NCT05040451 | Withdrawn

• 1 other identifier: CVP-3500-01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in MR Volume

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

  6 Months

Secondary Outcomes (14)

• Change of MR Severity: Quantitative MR Variables

  1, 6 & 12 Months

• Change of MR severity: Semi-Quantitative Parameter (1)

  1, 6 & 12 Months

• Change of MR severity: Semi-Quantitative Parameter (2)

  1, 6 & 12 Months

• Change of MR severity: Semi-Quantitative Parameter (3)

  1, 6 & 12 Months

• Change in Left Atrial Area

  1, 6 & 12 Months

Interventions

Carillon Mitral Contour System DEVICE

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.

Eligibility Criteria

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

Study Population

Consent up to 150 subjects suffering from heart failure and presenting with functional mitral regurgitation in order to implant 30 subjects, plus up to 3 "roll-in" subjects per site

You may qualify if:

• Mild-moderate-to-severe secondary MR (as assessed by qualitative, semi-quantitative and/or quantitative echocardiographic assessment (Zoghbi, JASE 2017)) in the setting of all of the following (a-d, below):
• Symptomatic functional (secondary mitral regurgitation defined as both: 1+ (mild) 2+ (Moderate), or 3+ (Moderate/Severe)
• Exacerbation of MR with exercise by at least one grade or 10 mm2 EROA
• Left Ventricular Ejection Fraction ≤50% by Simpson's biplane technique
• LVEDD \>5.5 cm
• 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
• 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 βHCG 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

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: September 10, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share