NCT04157920

Impact of Predilatation Between Self-expanding Valves

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation with ACURATE NEO/TF	Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation
DEVICE	Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro	Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-04-01
• Completion: 2022-07-20
• First posted: 2019-11-08
• Last updated: 2023-12-26

Locations

1 site across 1 country: Greece