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 range18 Years
SexALL
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
✓. 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
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
. 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.