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Functional Assessment in TAVI: FAITAVI
Sponsor: Universita di Verona
Summary
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies: 1. the Angiographically-guided strategy; 2. the Physiologically-guided strategy.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2017-11-24
Completion Date
2025-06
Last Updated
2025-03-21
Healthy Volunteers
No
Interventions
Physiologically-guided strategy
The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches \>2.5mm, with a % coronary stenosis\>50% as evaluated by visual estimation. The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR \>0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values \>0.80 that show a discrepancy with positive (\<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy
Locations (1)
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy