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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
RECRUITING
New York
Contact Information
Primary
Kate Dalton, MS, RD, CCRC
keb2114@cumc.columbia.edu
(347) 514-3366
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2027-11
Participants
Target number of participants: 60
Treatments
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.
Sponsors
Leads: Columbia University
Collaborators: Abbott

This content was sourced from clinicaltrials.gov