Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair (MitraFLOW)

Impact of Mitral Valve Regurgitation on Coronary Haemodynamics and the Instantaneous Effect of Transcatheter Mitral Valve Repair: The MitraFLOW Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Mitral Regurgitation; Mitral Valve Insufficiency; Coronary Stenosis
• Intervention / Treatment: Procedure: Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcatheter Mitral Valve Repair arm; 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.; Other Names: MitraClip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Mitral Regurgitation; MitraClip; iFR; Coronary microcirculation; Coronary hemodynamics
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Coronary Disease; Coronary Artery Disease; Mitral Valve Insufficiency; Coronary Stenosis
• Other Study ID Numbers: 2019-0000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No