Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04663334 |
Other study ID # |
AP001 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 8, 2020 |
Est. completion date |
May 8, 2023 |
Study information
Verified date |
December 2023 |
Source |
Nantes University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic
Valve Implantation in patients with concomitant coronary artery disease and severe aortic
stenosis.
Severe aortic stenosis is the most common indication of valvular replacement in developed
countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic
stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its
prognostic impact is not clearly established, and available studies uncommonly used
functional assessment of severity from a coronary stenosis to stratify the risk in this
situation.
Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous
coronary intervention (PCI) in clinical practice. Its use is not validated in patients with
severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to
microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After
aortic valvular replacement, a myocardial reverse remodeling is described, generating a
decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary
microcirculatory reserve is not known. Some studies have shown improvement in coronary
reserve immediately after TAVI and this effect seemed to last long after treatment.
The aim of the study is to assess the effects of inverse myocardial remodeling on coronary
microcirculatory function and its association with FFR values before and after TAVI.
Description:
This monocentric and prospective observational study aims to include patients with stable
coronary artery disease and undergoing TAVI for severe aortic stenosis via transfemoral
access, from November 2020 at Nantes University Hospital, France.
All patients have severe symptomatic aortic stenosis, secondary to degenerative disease
confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2)
and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography
performed in systematic preoperative work-up. These patients are deemed for TAVI and a
first-line medical treatment for CAD, after heart team decision.
The collegially chosen strategy to manage CAD in this population consists in assessing
hemodynamic parameters from a coronary stenosis during the TAVI procedure, using functionals
tests for ischemia (FFR, IMR, CFR) from a concomitant coronarography. Patients will be
routinely admitted in hospital 6 months after TAVI, for clinical and echocardiographic
reassessment, and coronarography control. Functional tests will be repeated and according to
results, continuation of medical therapy or PCI is proposed, at operator's discretion.
All procedures are performed within the same site by 1 medical team including 4
interventional cardiologists.
Before the TAVI procedure, a computerized multi-sliced tomography is systematically performed
to validate the percutaneous approach by femoral access and to choose which prothesis model
will be used.
In most cases, TAVI procedure are performed under local anesthesia and mild sedation, under
anesthetist supervision.
The common femoral artery is punctured by percutaneous approach, above the femoral
bifurcation and a 16-French sheath is inserted.
Three available models of aortic bioprothesis are implanted in our center, the Sapien 3
(EDWARDS Lifescience) the Corevalve Evolute R (Metdtronik) and the Accurate Neo 2 (Boston
Scientific) Two Perclose ProGlide devices (Abbott Vascular) are used to perform the
perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed
and the nodes from the two previously placed ProGlide devices are tightened. Final femoral
angiographic control is not systematic.
Concomitant coronarography is performed by radial artery access site, using a 6-French
sheath.
Hemodynamics measures are recorded by PressureWire X Guidewire (Abott Vascular) wireless
devices to a computer and processed by the CoroFlow Coroventis software (Abbott Vascular) to
carry out multimodal physiological evaluation. FFR, CFR, and IMR measures will be repeated
before and immediately after valve implantation. These parameters will be reassessed 6 months
after TAVI.