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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04529928




Registration number
NCT04529928
Ethics application status
Date submitted
25/08/2020
Date registered
28/08/2020

Titles & IDs
Public title
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
Scientific title
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
Secondary ID [1] 0 0
CVP-3473-01
Universal Trial Number (UTN)
Trial acronym
AFIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Mitral Regurgitation 0 0
Atrial Fibrillation 0 0
Atrial Functional Mitral Regurgitation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Carillon Mitral Contour System

Experimental: Implanted - Subjects successfully implanted with the Carillon Mitral Contour System


Treatment: Devices: Carillon Mitral Contour System
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline
Timepoint [1] 0 0
6 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
11. Uncontrolled hypertension (BP > 180 mmHg systolic and/or >105 mmHg diastolic) or hypotension (BP < 90 mmHg systolic) at baseline
12. Presence of severe mitral annular calcification
13. Prior mitral valve surgery
14. Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or mitral annuloplasty ring
15. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
16. Active endocarditis
17. Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation
18. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
19. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than atrial functional mitral regurgitation
20. Subjects with echocardiographic documentation of non-compaction cardiomyopathy with associated hypercontractility of the cardiac structures supporting the mitral annulus
21. Hemodynamic instability requiring inotropic support or mechanical heart circulatory support
22. Active infections requiring current antibiotic therapy
23. Severe right ventricular failure or severe tricuspid regurgitation
24. History of bleeding diathesis or coagulopathy, or subject who refuses blood transfusions
25. 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)
26. Allergy to contrast dye that cannot be pre-medicated
27. Pregnant or planning pregnancy within next 12 months.
28. Chronic severe pathology limiting survival to less than 12-months in the judgement of the investigator
29. Anticipated need of left ventricular assist device within twelve (12) months
30. Currently participating or has participated in another investigational study where the study primary endpoint was not reached at the time of screening
31. Patient requires emergent/emergency treatment for mitral regurgitation

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2022
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Thessaloníki

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cardiac Dimensions Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04529928