Monitoring heart function with a wireless sensor for heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CardioClip study investigates the use of a wireless sensor to continuously monitor pulmonary artery pressure in patients with heart failure and mitral regurgitation. This sensor is implanted using a minimally invasive procedure similar to the mitral transcatheter edge-to-edge repair (mTEER). By providing real-time data on heart function, the study aims to enable healthcare providers to adjust treatments more effectively, potentially improving patient outcomes. The findings could inform future research on the benefits of wireless monitoring in managing valve disease and heart failure.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Nir Uriel, MD — Columbia University
• Study coordinator: Kate Dalton, MS, RD, CCRC
• Email: keb2114@cumc.columbia.edu
• Phone: (347) 514-3366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ring-style blood pressure bracelet test compared with 24-hour monitoring in people with HFrEF

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• HFrEF polypill strategy in Sri Lanka

  This study tests whether giving a heart failure polypill can reduce death from heart disease and hospitalizations in adults with HFrEF in Sri Lanka, compared with usual care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.