heart failure heart failure
Conditions
Interventions
Carillon Mitral Contour System® (CMCS) - Model XE2
The CMCS received CE-Mark on 3 August 2011.
In Australia the CMCS received approval from TGA on 25 August 2020.
Sponsors
Cardiac Dimensions
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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)
Exclusion criteria
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 *mol/L) OR estimated Glomerular Filtration Rate (eGFR) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Change in mitral regurgitant volume (mL) associated with the Carillon device at 6 months post-implant, as compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * MR severity as assessed by echocardiography at Day One, 1 month, 6 months and 12 months, in accordance with American Society of Echocardiography guidelines, compared to baseline. Semi-quantitative parameters to be assessed include vena contracta width, MV EVmax, pulmonary vein flow). Quantitative MR variables to be assessed include regurgitant volume (mL), regurgitant fraction (%) and effective regurgitant orifice area (cm2, EROA) by Proximal Isovelocity Surface Area (PISA). * Change in Left Atrial Area, Diameter and LA Volume Index at 1, 6 and 12 months over baseline * Change in Left Atrial Diameter and Area at 1, 6 and 12 months over baseline * Change in Left Ventricular End Diastolic Volume (LVEDV) at 1, 6 and 12 months over baseline * Change in Left Ventricular End Systolic Volume (LVESV) at 1, 6 and 12 months over baseline * Change in Pulmonary Artery Systolic Pressure at 1, 6 and 12 months over baseline * Change in Right Ventricular size (base and mid) at 1, 6 and 12 months over baseline * Change in 6 Minute Walk Test (6MWT) distance at 1, 6 and 12 months over baseline * Change in Quality of Life (QoL) score as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1, 6 and 12 months over baseline * Change in Quality of Life (QoL) score as measured by Short Form-36 (SF-36) at 1, 6 and 12 months over baseline * Change in New York Heart Association (NYHA) Functional Classification at 1, 6 and 12 months over baseline * Hospitalization for heart failure at 1, 6 and 12 months * Stroke, myocardial infarction, cardiovascular and all-cause mortality at 1, 6 and 12 months * Need for mitral valve intervention or surgery at 1, 6 and 12 months | — |
Countries
Netherlands
Outcome results
None listed