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.
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 Type
OBSERVATIONAL
Enrollment
250
The Cardiac Dimensions Carillon Mitral Contour System (CMCS) is a medical device and consists of the following components: 1. A proprietary implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV) 2. A catheter-based delivery system which consists of a curved CMCS delivery catheter (3.2mm outer diameter) and a handle assembly 3. A sizing catheter to enable the physician to estimate the overall CS/GCV dimensions so that an appropriately sized implant may be selected The implant is attached to the handle assembly and is delivered through the CMCS delivery catheter to the coronary vein along the posterolateral aspect of the mitral annulus. The implant is designed to re-shape the mitral annulus to reduce annular dilation and mitral regurgitation.
Universitätsklinikum Aachen
Aachen, Germany
St. Marien Krankenhaus- Ahaus Vreden
Ahaus, Germany
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 6 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 12 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 24 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 3 years
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 4 years
Death
All cause mortality including cardiovascular and non-cardiovascular death
Time frame: 5 years
Serious adverse events
Number of procedure related or device related serious adverse events
Time frame: 6 months
Serious adverse events
Number of procedure related or device related serious adverse events
Time frame: 12 months
Change in New York Heart Association (NYHA) classification
Change in New York Heart Association (NYHA) Functional Classification at 6, 12, and 24 months, and 3, 4, and 5 years
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
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Sana Klinikum Lichtenberg
Berlin, Germany
Klinikum Links der Weser
Bremen, Germany
Kardiovaskular Zentrum Darmstadt
Darmstadt, Germany
Herzzentrum Dresden
Dresden, Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany
Universtitätsklinikum Frankfurt
Frankfurt, Germany
Hostpital zum Heiligen Geist
Fritzlar, Germany
Asklepios Klinik Altona
Hamburg, Germany
...and 9 more locations
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 6 months
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 12 months
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 24 months
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 3 years
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 4 years
Rate of Heart Failure Hospitalizations
Rate of hospitalization for heart failure
Time frame: 5 years
Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL)
change in MR severity based in regurgitant volume as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%)
change in MR severity based on regurgitant fraction (%) as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 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)
change in MR severity based on effective regurgitant orifice area (cm2, EROA) as assessed by by Proximal Isovelocity Surface Area (PISA) via echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width
Change in vena contract width MR severity as assessed by echocardiography in hospital 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax.
Change in MV EVmax MR severity as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow.
Change in pulmonary vein flow MR severity as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change in Left Atrial Area
Change in Left Atrial Area as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change in Left Atrial Diameter
Change in Left Atrial Diameter as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change in Left Atrial Volume Index
Change in Left Atrial Volume as assessed by echocardiography Index at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6, 12, and 24 months, and 3, 4, and 5 years
Change in Left Ventricular End Systolic Volume (LVESV)
Change in Left Ventricular End Systolic Volume (LVESV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in Left Ventricular End Diastolic Volume (LVEDV)
Change in Left Ventricular End Diastolic Volume (LVEDV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in Left Ventricular End Systolic Diameter (LVESD)
Change in Left Ventricular End Systolic Diameter (LVESD) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in Left Ventricular End Diastolic Diameter (LVEDD)
Change in Left Ventricular End Diastolic Diameter (LVEDD) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in Left Ventricular End Ejection Fraction (LVEF)
Change in Left Ventricular End Ejection Fraction (LVEF) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in exercise tolerance by walking
Change in exercise tolerance as measured by meters walked in Six Minute Walk Test at 6,12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years
Change in Quality-of-Life Overall Score
Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6,12, and 24 months, and 3, 4, and 5 years over baseline
Time frame: 6,12, and 24 months, and 3, 4, and 5 years