The CardioClip Study

Heart Failure With Reduced Ejection Fraction Clinical Trial

— CardioClip  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241430
• Other study ID #: AAAU9731
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Columbia University
• Contact: Kate Dalton, MS, RD, CCRC
• Phone: (347) 514-3366
• Email: keb2114[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure. Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications. While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• CardioMEMS
Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

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