An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitr… (NCT04529928) | Clinical Trial Compass
TerminatedNot Applicable
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
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.
Australia, Greece4 participantsStarted 2020-10-19
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline
. 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
Exclusion criteria
. 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