NCT04245956

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-08
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2020-01-29
• Last updated: 2025-02-04

Locations

1 site across 1 country: Switzerland