Impact of Mitral Regurgitation on Coronary Haemodynamics & Instantaneous

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04245956
Study type	Interventional
Source	University Hospital, Geneva
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 8, 2020
Completion date	January 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms