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Impact of Predilatation Between Self-expanding Valves — DIRECTII  

Aortic Stenosis Clinical Trial

Official title:
Impact of Balloon Predilatation Between Self-expanding Valves in All Comers Undergoing TAVI

Clinical Trial Summary

A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.

Clinical Trial Description

The aim of the present prospective, multicenter, non-randomized trial is to compare the device success rate and the in-hospital and 30-day safety and echocardiographic clinical outcomes between TAVI with and without predilatation in all comers undergoing implantation of self-expanding valves. Primary endpoint will be device success rate as defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality, cardiovascular mortality, stroke, acute kidney injury, life-threatening or disabling bleeding, major vascular complication, as well as the echocardiographic outcomes and valve performance as designated by the VARC-2 definitions at 30 days. VARC-1 and VARC-3 device success rates will be estimated as well. Study type: Observational Estimated Enrollment: 75 patients Allocation: Non - randomized, all comers Primary Purpose: Treatment Observational Model: Case-Control Condition or disease: Aortic valve stenosis Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system Time Perspective: Prospective Participating centers: Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change. Methods: Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04157920
Study type Interventional
Source National and Kapodistrian University of Athens
Contact
Status Completed
Phase N/A
Start date September 17, 2019
Completion date July 20, 2022
View Details
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