Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- Coronary Stenosis
- Mitral Regurgitation
- Mitral Valve Insufficiency
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: MitraFLOW is a prospective, investigator-initiated, monocentric, open-label, non-randomized pilot study.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04245956
- Collaborators
- Not Provided
- Investigators
- Not Provided