NOT_YET_RECRUITING
I'm interested ...!!
The CardioClip Study
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 Start (Actual) February 2024
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 27 January 2024
  • First Submitted that Met QC Criteria 27 January 2024
  • First Posted 5 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 January 2024
  • Last Update Posted 5 February 2024
  • Last Verified January 2024
I'm interested ...!!