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

NCT04245956 | Terminated DMC

• 1 other identifier: 2019-0000
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Insufficiency; Coronary Stenosis; Mitral Regurgitation; Coronary Artery Disease

Keywords

Mitral Regurgitation; MitraClip; iFR; Coronary microcirculation; Coronary hemodynamics

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Transcatheter Mitral Valve Repair arm

EXPERIMENTAL

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

Interventions

Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire PROCEDURE

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

Transcatheter Mitral Valve Repair arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Systolic pulmonary artery pressure \> 70 mmHg on baseline echocardiography;
• Significant contraindication to adenosine administration (e.g. heart block, severe asthma);
• Extremely calcified or tortuous vessels precluding invasive coronary physiology measurement;
• 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;
• Hypertrophic cardiomyopathy, restrictive pericarditis, constrictive pericarditis, infiltrative cardiomyopathy;
• Participation or planned participation in another clinical trial, except for observational registries;
• Patients unable or unwilling to provide written informed consent

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: MitraFLOW is a prospective, investigator-initiated, monocentric, open-label, non-randomized pilot study.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: January 29, 2020
• Study Start: January 8, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

CH (1)