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Impact of Predilatation Between Self-expanding Valves

NCT04157920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-12-26

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis

Interventions

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

Sponsors & Collaborators

  • Naval Hospital, Athens

    collaborator OTHER

  • Silesian Centre for Heart Diseases

    collaborator OTHER

  • University General Hospital of Heraklion

    collaborator OTHER

  • Interbalkan Medical Center, Thessaloniki, Greece

    collaborator UNKNOWN

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Konstantinos P Toutouzas, Professor · Professor of Cardiology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2021-04-01
Completion
2022-07-20

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04157920 on ClinicalTrials.gov