CardioClip
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
Sponsor study identifier
Secondary identifiers
interventional
60
1 country
1
Study Start
December 18, 2024
Actual (reported)Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2024
Actual (reported)February 5, 2024
Actual (reported)December 18, 2024
Actual (reported)June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.
12 months
All-cause mortality rate at 12 months
12 months
Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.
Participants randomized to this arm will receive usual care involving GDMT.
Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032, United States
Nir Uriel, MD
Columbia University
Michael Brener, MD
Columbia University
First Submitted
January 27, 2024
First Posted
February 5, 2024
Study Start
December 18, 2024
Actual (reported)Rate of HFH at 12 months
12 months
Number of participants who achieve excellent clinical outcome
12 months
KCCQ score - Physical Function domain
Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Social Function domain
Baseline, 1 month, 6 months, 12 months post-mTEER
Contact the study team to confirm eligibility.
Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 29, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: