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TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

NCT02729519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-09-30

No results posted yet for this study

Summary

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

TAVI

standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Florence LECLERCQ, MD,PhD · UH of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-08
Primary Completion
2018-06-29
Completion
2018-08-09

Countries

  • France

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 NCT02729519 on ClinicalTrials.gov