Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 11:37 PM
Study NCT ID:
NCT04245956
Status:
TERMINATED
Last Update Posted:
2025-02-04
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Impact of Mitral Valve Regurgitation on Coronary Haemodynamics and the Instantaneous Effect of Transcatheter Mitral Valve Repair: The MitraFLOW Study
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrolment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MitraFLOW
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: