An interventional study of Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire in Mitral Valve Insufficiency, Coronary Stenosis and Mitral Regurgitation, sponsored by University Hospital, Geneva. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Diagnostic
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.
Consecutive patients with significant degenerative or functional MR planned for TMVR using the percutaneous edge-to-edge MitraClip system will be assessed for study eligibility. Patients with documented concomitant coronary artery disease, defined as coronary artery stenosis of 50% diameter or more in at least 1 epicardial coronary artery, will be informed about the study. Written informed consent will be obtained from all patients before enrolment in the study.
The TMVR procedure will be performed under general anesthesia with fluoroscopy and transesophageal echocardiographic guidance using the MitraClip device via a femoral venous approach. Cardiac catheterisation and coronary angiography will be undertaken via the transradial route, using standard equipment. The hemodynamic data listed below will be acquired immediately before and after TMVR.
For all lesions, intracoronary blood flow and pressure measurements will be used to generate the following intracoronary physiological parameters:
Post-procedural evaluation: Patients will be followed up according to local standard clinical practice.
467 studies on the registry are indexed under Mitral Valve Insufficiency; 152 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 279 interventional studies indexed under Mitral Valve Insufficiency.
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Exclusion Criteria:
Patients with severe Mitral Insufficiency with concomitant intermediate coronary artery stenosis undergoing Transcatheter Mitral Valve Repair using the percutaneous edge-to-edge MitraClip system
Procedure: Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire
The intervention consists of measuring a series of hemodynamic indices in a stenosed coronary using a pressure wire, immediately before and after transcatheter mitral valve repair using the percutaneous edge-to-edge MitraClip system in patients with severe mitral insufficiency and concomitant intermediate coronary artery stenosis.
Also known as: MitraClip
Change from baseline of Fractional Flow Reserve (FFR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Fractional Flow Reserve (FFR).
Time frame: Immediately post TMVR
Change from baseline of instantanepous wave free ration (iFR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the instantanepous wave free ration (iFR).
Time frame: Immediately post TMVR
Change from baseline of Resting Full-Cycle Ratio (RFR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Resting Full-Cycle Ratio (RFR).
Time frame: Immediately post TMVR
Change from baseline of Absolute coronary Blood Flow (ABF), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Absolute coronary Blood Flow (ABF).
Time frame: Immediately post TMVR
Change from baseline of Coronary Flow Reserve (CFR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Coronary Flow Reserve (CFR).
Time frame: Immediately post TMVR
Change from baseline of the Index for Microvascular Resistance (IMR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Index for Microvascular Resistance (IMR).
Time frame: Immediately post TMVR
Change from baseline of the Baseline Resistance Index (BRI), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Baseline Resistance Index (BRI).
Time frame: Immediately post TMVR
Change from baseline of the Resistance Reserve Ratio (RRR), after Transcatheter Mitral Valve Repair (TMVR).
The primary endpoint of the study is the invasive pressure-derived physiological assessment of angiographically-documented intermediate coronary artery lesions before and after TMVR of the Resistance Reserve Ratio (RRR).
Time frame: Immediately post TMVR
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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