RECRUITING

The CardioClip Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-11
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06241430

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Significant (moderate-severe \[3+\] or severe \[4+\] secondary MR)
  2. * Left ventricular dysfunction (ejection fraction \>20% and \<50%)
  3. * New York Heart Association (NYHA) class II-IVa symptoms
  4. * Sign informed consent to participate in the study
  1. * Left ventricular (LV) end-systolic dimension 70 mm
  2. * PA systolic pressure 70 mmHg (fixed)
  3. * Mitral valve (MV) orifice area \<4.0 cm2
  4. * Commissural MR jet or leaflet anatomy not suitable for mTEER
  5. * Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
  6. * Recurrent (i.e., \>1) pulmonary embolism or deep vein thrombosis
  7. * Complex congenital heart disease
  8. * Mechanical right heart valve (tricuspid or pulmonic)
  9. * Cardiac resynchronization therapy implanted within 3 months of enrollment
  10. * Hypersensitivity to aspirin and/or clopidogrel
  11. * History of medication non-adherence

Contacts and Locations

Study Contact

Kate Dalton, MS, RD, CCRC
CONTACT
(347) 514-3366
keb2114@cumc.columbia.edu

Principal Investigator

Nir Uriel, MD
PRINCIPAL_INVESTIGATOR
Columbia University
Michael Brener, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

  • Nir Uriel, MD, PRINCIPAL_INVESTIGATOR, Columbia University
  • Michael Brener, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-11
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Heart Failure With Reduced Ejection Fraction
  • Mitral Regurgitation