The CardioClip Study

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06241430
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 18, 2024
Status verified
Jun 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032
Kate Dalton, MS, RD, CCRC
[email protected]
Nir Uriel, MD (PRINCIPAL_INVESTIGATOR)
Michael Brener, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital· New York, NY

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