The CardioClip Study

Description

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

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Study Overview

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Study Details

Study overview

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.

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

The CardioClip Study

Condition
Heart Failure With Reduced Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Nir Uriel, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Michael Brener, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2027-11