Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
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:

 -  Fractional Flow Reserve, FFR.

 -  Absolute coronary Blood Flow, ABF.

 -  Coronary Flow Reserve, CFR.

 -  Index for Microvascular Resistance, IMR.

 -  Baseline Resistance Index, BRI.

 -  Resistance Reserve Ratio, RRR.

 -  Instantaneous wave-free ratio, iFR

 Post-procedural evaluation: Patients will be followed up according to local standard clinical
 practice.
Inclusion Criteria:

 1. Age ≥18 years;

 2. Patients with significant degenerative or functional MR planned for TMVR with the
 percutaneous edge-to-edge mitral valve repair MitraClip system;

 3. Patients with ≥ 1 coronary artery lesion with angiographically-documented ≥50%
 diameter stenosis,

 4. Patient willing and able to provide written informed consent.

 Exclusion Criteria:

 1. Previous coronary artery bypass surgery;

 2. Presence of ≥1 coronary total occlusion(s);

 3. Documented non-viable myocardium in the area of the corresponding coronary artery
 being studied;

 4. Severe left ventricular systolic dysfunction (<30%);

 5. 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;

 6. Systolic pulmonary artery pressure > 70 mmHg on baseline echocardiography;

 7. Significant contraindication to adenosine administration (e.g. heart block, severe
 asthma);

 8. Extremely calcified or tortuous vessels precluding invasive coronary physiology
 measurement;

 9. Acute coronary syndrome with recent ST-elevation myocardial infarction <5 days prior
 to randomization, or ongoing non-ST elevation acute coronary syndrome with biomarkers
 (cardiac troponin) still rising;

 10. Hypertrophic cardiomyopathy, restrictive pericarditis, constrictive pericarditis,
 infiltrative cardiomyopathy;

 11. Participation or planned participation in another clinical trial, except for
 observational registries;

 12. Patients unable or unwilling to provide written informed consent