Functional Assessment in TAVI: FAITAVI

NAActive, not recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

November 24, 2017

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2025

Conditions
Coronary Artery DiseaseAortic Valve Stenosis
Interventions
DEVICE

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"

Trial Locations (1)

37126

Azienda Ospedaliera Universitaria Integrata Verona, Verona

All Listed Sponsors
lead

Universita di Verona

OTHER

NCT03360591 - Functional Assessment in TAVI: FAITAVI | Biotech Hunter | Biotech Hunter