Coronary Artery Disease Clinical Trial
— MitraFLOWOfficial title:
Impact of Mitral Valve Regurgitation on Coronary Haemodynamics and the Instantaneous Effect of Transcatheter Mitral Valve Repair: The MitraFLOW Study
Verified date | May 2024 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospitals | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR | |
Primary | 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). | Immediately post TMVR |
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