Clinical trial NCT06241430: The CardioClip Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Mitral Regurgitation
Keywords: Heart failure
Reduced ejection fraction
Mitral regurgitation
mTEER (mitral transcatheter edge-to-edge repair)
CardioMems (implantable pulmonary artery pressure sensor)
Guideline-directed medical therapy (GDMT)
HF hospitalization (HFH)
Clinical trial
Hemodynamic monitoring
Cardiovascular outcomes
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2024-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluating the effect of hemodynamic-guided GDMT titration with CardioMems on HFH in individuals with functional MR and HF undergoing mTEER, compared to usual care involving GDMT.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality rate at 12 months
timeFrame: 12 months
measure: Rate of HFH at 12 months
timeFrame: 12 months
measure: Number of participants who achieve excellent clinical outcome
timeFrame: 12 months
measure: KCCQ score - Physical Function domain
timeFrame: Baseline, 1 month, 6 months, 12 months post-mTEER
measure: KCCQ score - Social Function domain
timeFrame: Baseline, 1 month, 6 months, 12 months post-mTEER
measure: KCCQ score - Symptoms domain
timeFrame: Baseline, 1 month, 6 months, 12 months post-mTEER
measure: KCCQ score - Quality of Life domain
timeFrame: Baseline, 1 month, 6 months, 12 months post-mTEER
measure: Change in New York Heart Association (NYHA) Classification at 1-, 6-, and 12-months post-mTEER relative to baseline.
timeFrame: Baseline, 1 month, 6 months, 12 months
measure: 6-minute walk test (6MWT) at 12 months
timeFrame: 12 months
measure: Change in 6-minute walk test (6MWT) from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Win ratio
timeFrame: Baseline and 12 months
measure: Echocardiographic estimates of RV-PA coupling indices
timeFrame: 12 months
measure: Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)
timeFrame: 12 months
measure: Single-leaflet Device Detachments
timeFrame: 12 months
measure: Device Embolizations (MitraClip)
timeFrame: 12 months
measure: Endocarditis (Requiring Surgery)
timeFrame: 12 months
measure: Mitral Stenosis (Requiring Surgery)
timeFrame: 12 months
measure: Device- or System-related Failures
timeFrame: 12 months
measure: In Situ Pulmonary Thrombosis
timeFrame: 12 months
measure: Device Embolizations (CardioMEMS)
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Nir Uriel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Michael Brener, MD
role: PRINCIPAL_INVESTIGATOR
References: