Status:
ACTIVE_NOT_RECRUITING
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Lead Sponsor:
University of Zurich
Conditions:
Aortic Stenosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percu...
Detailed Description
The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of corona...
Eligibility Criteria
Inclusion
- Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team.
- Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria:
- Dyspnea
- Angina symptoms
- Syncope
- Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines.
- At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator.
- Written informed consent.
Exclusion
- TAVI by transapical, subclavian, or transaortic access
- Admission with acute myocardial infarction within 30 days before randomization
- Elective coronary revascularization within 3 months before randomization
- Previous coronary artery bypass grafting (CABG)
- Syntax Score I ≥33
- Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
- Planned open heart surgery
- Known pregnancy at the time of inclusion
- Life expectancy \<1 year due to other severe non-cardiac disease
- Participation in another clinical study with an investigational product
- Acute COVID-19 infection
- Patient with previously treated aortic stenosis
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
986 Patients enrolled
Trial Details
Trial ID
NCT04310046
Start Date
September 30 2020
End Date
July 1 2031
Last Update
September 17 2025
Active Locations (1)
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1
University Hospital Zürich, Cardiology Department
Zurich, Switzerland, 8091