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The preDIlatation in tRanscathEter aortiC Valve implanTation Trial

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clinicaltrials.gov/study/NCT02448927
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT024489270
Trial Recruitment Size
1700
Trial Sponsor
National and Kapodistrian University of Athens
National and Kapodistrian University of Athens
0
Clinical Trial Start Date
2015
0
Primary Completion Date
May 2, 2018
0
Study Completion Date
May 2, 2018
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Intervention Name
Transcatheter Aortic Valve Implantation0
balloon aortic valvuloplasty0
Interventional Trial Phase
Phase 30
Official Name
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial0
Last Updated
September 6, 2019
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Triple0
Masked Party
Investigator0
Outcomes Assessor0
Participant0
Study summary

This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure. Patients will undergo a physical exam, coronary angiography and computed tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of all the imaging modalities for each patient. The patients will be followed during the hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of predilatation will be at the operator's discretion.

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