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

Primary Purpose

Mitral Valve Insufficiency, Coronary Stenosis, Mitral Regurgitation

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mitral Valve Insufficiency focused on measuring Mitral Regurgitation, MitraClip, iFR, Coronary microcirculation, Coronary hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Mitral Valve Repair arm

Arm Description

Patients with severe Mitral Insufficiency with concomitant intermediate coronary artery stenosis undergoing Transcatheter Mitral Valve Repair using the percutaneous edge-to-edge MitraClip system

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
July 17, 2019
Last Updated
December 4, 2022
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04245956
Brief Title
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
Acronym
MitraFLOW
Official Title
Impact of Mitral Valve Regurgitation on Coronary Haemodynamics and the Instantaneous Effect of Transcatheter Mitral Valve Repair: The MitraFLOW Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Coronary Stenosis, Mitral Regurgitation, Coronary Artery Disease
Keywords
Mitral Regurgitation, MitraClip, iFR, Coronary microcirculation, Coronary hemodynamics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
MitraFLOW is a prospective, investigator-initiated, monocentric, open-label, non-randomized pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Mitral Valve Repair arm
Arm Type
Experimental
Arm Description
Patients with severe Mitral Insufficiency with concomitant intermediate coronary artery stenosis undergoing Transcatheter Mitral Valve Repair using the percutaneous edge-to-edge MitraClip system
Intervention Type
Procedure
Intervention Name(s)
Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire
Other Intervention Name(s)
MitraClip
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of Fractional Flow Reserve (FFR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of instantanepous wave free ration (iFR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of Resting Full-Cycle Ratio (RFR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of Absolute coronary Blood Flow (ABF), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of Coronary Flow Reserve (CFR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of the Index for Microvascular Resistance (IMR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of the Baseline Resistance Index (BRI), after Transcatheter Mitral Valve Repair (TMVR).
Description
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
Title
Change from baseline of the Resistance Reserve Ratio (RRR), after Transcatheter Mitral Valve Repair (TMVR).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

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

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