The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 250
- Locations
- 19
- Primary Endpoint
- Death
Study Overview
Brief Summary
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon® Mitral Contour System® (CMCS) in a commercial (post market) setting.
Detailed Description
There are more than 22 million people worldwide with heart failure, including 5.3 million in the United States . Functional mitral regurgitation (MR), leakage of the mitral valve due to dilation of the left ventricle and annulus, occurs as a consequence of Heart Failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.
Previous studies have established that the Carillon® therapy has caused a significant reduction in functional MR. This reduction in MR results in clinically significant improvements in exercise tolerance, quality of life, and thus overall function in a symptomatic heart failure population.
To supplement the findings from these previous studies, Cardiac Dimensions is conducting this post-market registry of the Carillon® Mitral Contour System® (CMCS) in patients with functional mitral regurgitation. This registry is a retrospective and prospective, multi-center, clinical registry designed to further characterize the acute and long-term safety and performance profile of the CMCS. Up to 250 implanted patients will be enrolled at up to 40 centers located in the European Union and countries that recognize the CE-mark as a valid marketing authorization.
Patients enrolled in the registry have received the Carillon implant and will be assessed to document the long-term safety and performance of the device. These patients will be followed according to routine standard of care post procedure follow up assessments.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
- •Patients implanted with the Carillon device
- •Patients must be ≥ 18 years old
- •Patients require informed consent prior to inclusion in this registry
- •Minimum baseline data, as described in CINCH Protocol, including:
- •Hemodynamic measures (by echocardiography)
- •Baseline must include the following measurements: MR grade, LVEF (%), LVEDD, LAD, and AP & ML diameters
- •NYHA Classification
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Death
Time Frame: 5 years
All cause mortality including cardiovascular and non-cardiovascular death
Change in New York Heart Association (NYHA) classification
Time Frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change in New York Heart Association (NYHA) Functional Classification at 6, 12, and 24 months, and 3, 4, and 5 years
Rate of Heart Failure Hospitalizations
Time Frame: 5 years
Rate of hospitalization for heart failure
Serious adverse events
Time Frame: 12 months
Number of procedure related or device related serious adverse events
Secondary Outcomes
- Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%)(6, 12, and 24 months, and 3, 4, and 5 years)
- Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width(6, 12, and 24 months, and 3, 4, and 5 years)
- Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA)(6, 12, and 24 months, and 3, 4, and 5 years)
- Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax.(6, 12, and 24 months, and 3, 4, and 5 years)
- Change in Left Atrial Volume Index(6, 12, and 24 months, and 3, 4, and 5 years)
- Change in Quality-of-Life Overall Score(6,12, and 24 months, and 3, 4, and 5 years)
- Change in Left Atrial Area(6, 12, and 24 months, and 3, 4, and 5 years)
- Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL)(6, 12, and 24 months, and 3, 4, and 5 years)
- Change in Left Ventricular End Ejection Fraction (LVEF)(6,12, and 24 months, and 3, 4, and 5 years)
- Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow.(6, 12, and 24 months, and 3, 4, and 5 years)
- Change in Left Atrial Diameter(6, 12, and 24 months, and 3, 4, and 5 years)
- Change in Left Ventricular End Systolic Volume (LVESV)(6,12, and 24 months, and 3, 4, and 5 years)
- Change in Left Ventricular End Diastolic Volume (LVEDV)(6,12, and 24 months, and 3, 4, and 5 years)
- Change in Left Ventricular End Systolic Diameter (LVESD)(6,12, and 24 months, and 3, 4, and 5 years)
- Change in Left Ventricular End Diastolic Diameter (LVEDD)(6,12, and 24 months, and 3, 4, and 5 years)
- Change in exercise tolerance by walking(6,12, and 24 months, and 3, 4, and 5 years)