The CardioClip Study

NCT06241430 | Recruiting FDA Device

• 1 other identifier: AAAU9731
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.

  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). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.

  12 months

Secondary Outcomes (20)

• All-cause mortality rate at 12 months

  12 months

• Rate of HFH at 12 months

  12 months

• Number of participants who achieve excellent clinical outcome

  12 months

• KCCQ score - Physical Function domain

  Baseline, 1 month, 6 months, 12 months post-mTEER

• KCCQ score - Social Function domain

  Baseline, 1 month, 6 months, 12 months post-mTEER

Study Arms (2)

CardioMems

EXPERIMENTAL

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

Device: CardioMEMS

Usual Care

NO INTERVENTION

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

Interventions

CardioMEMS DEVICE

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

CardioMems

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Abbott: collaborator

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nir Uriel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Michael Brener, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Dalton, MS, RD, CCRC

CONTACT

(347) 514-3366; keb2114@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seymour, Paul, and Gloria Milstein Professor of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)