Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcathete… (NCT04245956) | Clinical Trial Compass
TerminatedNot Applicable
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
Stopped: Slow enrolment
Switzerland1 participantsStarted 2020-01-08
Plain-language summary
In the present study, the investigators aim to use the in-vivo Transcatheter Mitral Valve Repair (TMVR) model to determine how Mitral Regurgitation (MR) affects coronary hemodynamics in patients affected with severe MR and concomittant angiographically-documented coronary artery disease. The investigators will also provide unique physiologic data on the acute effect of TMVR using the MitraClip system on coronary microcirculation in patients with severe MR.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years;
✓. Patients with significant degenerative or functional MR planned for TMVR with the percutaneous edge-to-edge mitral valve repair MitraClip system;
✓. Patients with ≥ 1 coronary artery lesion with angiographically-documented ≥50% diameter stenosis,
✓. Patient willing and able to provide written informed consent.
Exclusion criteria
✕. Previous coronary artery bypass surgery;
✕. Presence of ≥1 coronary total occlusion(s);
✕. Documented non-viable myocardium in the area of the corresponding coronary artery being studied;
✕. Severe left ventricular systolic dysfunction (\<30%);
✕. Cardiogenic shock/hemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg) and/or need for mechanical/pharmacologic hemodynamic support;
What they're measuring
1
Change from baseline of Fractional Flow Reserve (FFR), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
2
Change from baseline of instantanepous wave free ration (iFR), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
3
Change from baseline of Resting Full-Cycle Ratio (RFR), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
4
Change from baseline of Absolute coronary Blood Flow (ABF), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
5
Change from baseline of Coronary Flow Reserve (CFR), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
6
Change from baseline of the Index for Microvascular Resistance (IMR), after Transcatheter Mitral Valve Repair (TMVR).
Timeframe: Immediately post TMVR
7
Change from baseline of the Baseline Resistance Index (BRI), after Transcatheter Mitral Valve Repair (TMVR).