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An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT04529928•Cardiac Dimensions Pty Ltd

View on ClinicalTrials.gov

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)

Detailed Description

The AFIRE Trial is a prospective, multi-center clinical trial. The centers will utilize pre-screening of existing medical records to identify potentially eligible subjects. Once informed consent has been obtained, the subject will undergo baseline assessments, which include: Transthoracic echocardiography, transesophageal echocardiography, and functional assessments (Six-Minute Walk Test, NYHA, and Quality of Life Questionnaires). Following final eligibility determination, eligible subjects will under the index procedure to implant the Carillon device (includes coronary sinus venogram). Subject will be discharged following one-night in-hospital stay and discharge assessments. Subjects who have the Carillon implant procedure attempted but were not successfully implanted (Non-Implanted subjects) will be followed through discharge or resolution of safety events, whichever is longer, and then discharged from the trial. Implanted subjects will have follow-up assessments performed at 1 month, 6 months, and 12 months post index procedure. Follow-up assessments will include transthoracic echocardiography, Six-Minute Walk Test, and Quality of Life Questionnaires.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. New York Heart Association (NYHA) Class II, III or ambulatory IV heart failure
•3. 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)
•4. Patient deemed appropriate candidate for transcatheter mitral valve repair by the local multidisciplinary heart team
•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. Female subjects of child-bearing potential must have a negative serum BHCG test
•7. Age ≥ 18 years old
•8. The subject has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study

Exclusion Criteria

•1. Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
•2. Evidence of transient ischemic attack or stroke within three (3) months prior to intervention
•3. Percutaneous coronary intervention in the last 30 days
•4. 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
•5. Subjects expected to require any percutaneous coronary intervention within 30 days of the index procedure.
•6. 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
•7. Presence of a coronary artery stent under the CS / GCV in the implant target zone
•8. Presence of left atrial appendage (LAA) clot.
•9. 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
•10. Poorly controlled atrial fibrillation or flutter, with poor ventricular rate control (\> 100 bpm resting HR), or other poorly controlled symptomatic brady- or tachy-arrhythmias
+21 more criteria

Locations (2)

Royal Prince Alfred

Sydney, New South Wales, Australia

European Interbalkan Medical Center

Thessaloniki, Greece

Key Dates

Start Date

October 19, 2020

Primary Completion Date

September 22, 2021

Completion Date

December 22, 2022

Last Updated

March 17, 2023

Enrollment

ACTUAL participants

Conditions

Functional Mitral RegurgitationAtrial FibrillationAtrial Functional Mitral Regurgitation

Interventions

Carillon Mitral Contour System

DEVICE

The CONFORM Pivotal Trial

NCT05147792

Atrial FibrillationStroke

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RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

NCT06935591

Atrial Fibrillation (AF)

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RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

Medtronic Terminate AF Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia