Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04663334
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2020-12-04
Brief Title:
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Change in Coronary Microcirculation and Fractional Flow Reserve After Transcatheter Aortic Valve Implantation in Patients With Concomitant Coronary Artery Disease and Severe Aortic Stenosis
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 andor 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 operators 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
All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography mean gradient 40 mmHg andor 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 operators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None