Recruiting

CardioClip

Sponsor:

Columbia University

Code:

NCT06241430

Conditions

Heart Failure With Reduced Ejection Fraction

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CardioMEMS

Study Details

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

Study ID

NCT06241430

Start date

Dec 18, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CardioMems

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

no intervention: Usual Care

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

Interventions

CardioMEMS

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kate Dalton, MS, RD, CCRC

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

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Kate Dalton, MS, RD, CCRC

keb2114@cumc.columbia.edu

Principal Investigator:

Nir Uriel, MD

More Information

Sponsor

Columbia University

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-29.