Functional Mitral RegurgitationAFIRENCT04529928
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
A study testing Carillon Mitral Contour System in people with Functional Mitral Regurgitation and Atrial Fibrillation, run by Cardiac Dimensions Pty Ltd at 2 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- What is being tested?
- Carillon Mitral Contour System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2020to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
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- 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
Who cannot join
- 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
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- 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
- Active endocarditis
- Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation
- Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than atrial functional mitral regurgitation
- Subjects with echocardiographic documentation of non-compaction cardiomyopathy with associated hypercontractility of the cardiac structures supporting the mitral annulus
- Hemodynamic instability requiring inotropic support or mechanical heart circulatory support
- Active infections requiring current antibiotic therapy
- Severe right ventricular failure or severe tricuspid regurgitation
- History of bleeding diathesis or coagulopathy, or subject who refuses blood transfusions
- 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)
- Allergy to contrast dye that cannot be pre-medicated
- Pregnant or planning pregnancy within next 12 months.
- Chronic severe pathology limiting survival to less than 12-months in the judgement of the investigator
- Anticipated need of left ventricular assist device within twelve (12) months
- Currently participating or has participated in another investigational study where the study primary endpoint was not reached at the time of screening
- Patient requires emergent/emergency treatment for mitral regurgitation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
Read the 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.
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Being tested
- Carillon Mitral Contour System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carillon Mitral Contour SystemDevice
Also called Carillon, Carillon Device, Carillon Implant
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.
| Study group | Role | What they receive |
|---|---|---|
| Implanted | Experimental | Subjects successfully implanted with the Carillon Mitral Contour System Receives: Device: Carillon Mitral Contour System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start19 Oct 2020
- Primary completion22 Sep 2021
- Study completion22 Dec 2022
Why it stopped: The study was not accruing subjects as expected, due to limits in hospital resources and staff as a result of the COVID pandemic in Europe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiac Dimensions Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529928
- Sponsor's protocol ID
- CVP-3473-01
- Acronym
- AFIRE
- Status last verified
- Mar 2023
- First submitted
- 25 Aug 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT04529928
- Acronym / sponsor ID
- AFIRE / CVP-3473-01
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not accruing subjects as expected, due to limits in hospital resources and staff as a result of the COVID pandemic in Europe.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cardiac Dimensions Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted | Experimental | Device: Carillon Mitral Contour SystemSubjects successfully implanted with the Carillon Mitral Contour System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carillon Mitral Contour SystemAlso: Carillon, Carillon Device, Carillon ImplantEligible 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. | Device | Implanted |
Primary outcome
Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: The study was not accruing subjects as expected, due to limits in hospital resources and staff as a result of the COVID pandemic in Europe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carillon Mitral Contour System in people with Functional Mitral Regurgitation and Atrial Fibrillation, run by Cardiac Dimensions Pty Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was not accruing subjects as expected, due to limits in hospital resources and staff as a result of the COVID pandemic in Europe.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.