Heart Failure With Reduced Ejection Fraction Clinical Trial
— CardioClipOfficial title:
Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Significant (moderate-severe [3+] or severe [4+] secondary MR) - Left ventricular dysfunction (ejection fraction >20% and <50%) - New York Heart Association (NYHA) class II-IVa symptoms - Sign informed consent to participate in the study Exclusion Criteria: - Left ventricular (LV) end-systolic dimension 70 mm - PA systolic pressure 70 mmHg (fixed) - Mitral valve (MV) orifice area <4.0 cm2 - Commissural MR jet or leaflet anatomy not suitable for mTEER - Likely to undergo heart transplantation or LV assist device implantation in the next 12 months - Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis - Complex congenital heart disease - Mechanical right heart valve (tricuspid or pulmonic) - Cardiac resynchronization therapy implanted within 3 months of enrollment - Hypersensitivity to aspirin and/or clopidogrel - History of medication non-adherence |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All cause-mortality or heart failure hospitalization (HFH) | A composite sum of all-cause mortality and heart failure hospitalization events will be calculated. | 12 months | |
Secondary | All-cause mortality rate at 12 months | All-cause mortality rate will be calculated at 12 months. | 12 months | |
Secondary | All-cause mortality rate at 24 months | All-cause mortality rate will be calculated at 24 months. | 24 months | |
Secondary | Rate of HFH at 12 months | Heart failure hospitalization (HFH) rate will be calculated. | 12 months | |
Secondary | Rate of HFH at 24 months | Heart failure hospitalization (HFH) rate will be calculated. | 24 months | |
Secondary | Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). | 12 months | |
Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 12 months | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). | Baseline and 12 months | |
Secondary | 6-minute walk test (6MWT) at 12 months | The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes at 12 months. | 12 months | |
Secondary | Change in 6-minute walk test (6MWT) from baseline to 12 months | The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes. Change of score at baseline and then at 12 months will be calculated. | Baseline and 12 months | |
Secondary | Echocardiographic estimates of RV-PA coupling indices | Right ventricular (RV)-pulmonary arterial (PA) (RV-PA) coupling indices will be measured (mm/mmHg) will be measured to determine how the right ventricle and pulmonary circulation interact. | 12 months | |
Secondary | N-terminal prohormone of brain natriuretic peptide (NT-proBNP) | Natriuretic Peptides: Median (with interquartile range) of NT-proBNP (pg/mL) will be calculated. | 12 months | |
Secondary | C-Reactive Protein (CRP) | Inflammatory Marker: Median (with interquartile range) of CRP (mg/dL) will be calculated. | 12 months | |
Secondary | Erythrocyte Sedimentation Rate (ESR) | Inflammatory Marker: Median (with interquartile range) of ESR (mn/hour) will be calculated. | 12 months | |
Secondary | Matrix Metalloproteinase-2 (MMP-2) | Matric Remodeling Proteins: Median (with interquartile range) of MMP-2 (ng/mL) will be calculated. | 12 months | |
Secondary | Matrix Metalloproteinase-9 (MMP-9) | Matric Remodeling Proteins: Median (with interquartile range) of MMP-9 (ng/mL) will be calculated. | 12 months | |
Secondary | Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery) | MitraClip complications | 12 months | |
Secondary | Single-leaflet Device Detachments | Device-related MitraClip complications: Total number of single-leaflet device detachment events. | 12 months | |
Secondary | Device Embolizations (MitraClip) | Device-related MitraClip complications: Total number of device embolizations. | 12 months | |
Secondary | Endocarditis (Requiring Surgery) | Device-related MitraClip complications: Total number of endocarditis events requiring surgery. | 12 months | |
Secondary | Mitral Stenosis (Requiring Surgery) | Device-related MitraClip complications: Total number of mitral stenosis events requiring surgery. | 12 months | |
Secondary | Device- or System-related Failures | Device-related CardioMEMS complications: Total number of device- or system-related failures. | 12 months | |
Secondary | In Situ Pulmonary Thrombosis | Device-related CardioMEMS complications: Total number of in situ pulmonary thrombosis. | 12 months | |
Secondary | Device Embolizations (CardioMEMS) | Device-related CardioMEMS complications: Total number of device embolizations | 12 months |
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