The CardioClip Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorColumbia University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CardioMEMS
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Abbott
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov