Status:
COMPLETED
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Lead Sponsor:
Nantes University Hospital
Conditions:
Severe Symptomatic Aortic Stenosis
Eligibility:
All Genders
18+ years
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 a...
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 ...
Eligibility Criteria
Inclusion
- Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended.
- patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient \>40 mmHg and/or valve area \<1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography \> or = to 50%)
Exclusion
- Severe CAD with tritroncular lesions or severe stenosis (\>90 %) of left main artery or proximal left anterior descending artery
- Lack of viability in myocardial territory of interest
- History of bypass coronary surgery or heart transplantation
- Severe left ventricular systolic dysfunction, characterized by an ejection fraction \< 35 %
- Severe renal impairment (Creatinine clearance \<30 ml/min/1.73 m2)
- Absolute contraindication to intravenous adenosin
- Pregnant or nursing women Patients under guardianship, curatorship, or protection of justice
Key Trial Info
Start Date :
December 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04663334
Start Date
December 8 2020
End Date
May 8 2023
Last Update
December 15 2023
Active Locations (1)
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1
CHU Nantes
Nantes, France, 44000