The CardioClip Study

NCT ID: NCT06241430

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2027-11-30

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CardioMems

Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.

Group Type: EXPERIMENTAL

CardioMEMS

Intervention Type: DEVICE

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

Usual Care

Participants randomized to this arm will receive usual care involving GDMT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CardioMEMS

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nir Uriel

Seymour, Paul, and Gloria Milstein Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nir Uriel, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Michael Brener, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kate Dalton, MS, RD, CCRC

Role: CONTACT

keb2114@cumc.columbia.edu

(347) 514-3366

Facility Contacts

Kate Dalton, MS, RD, CCRC

Role: primary

keb2114@cumc.columbia.edu

Other Identifiers

AAAU9731

Identifier Type: -

Identifier Source: org_study_id