Aortic Valve Stenosis Clinical Trial
Official title:
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial
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.
Background: Balloon aortic valvuloplasty (BAV) is a vital part of the transcatheter aortic
valve implantation (TAVI) procedure. There is a lack of long-term evidence in patients
undergoing direct TAVI without predilatation.
Trial: This is a prospective multi-center randomized trial.
Participating medical centers:
1. 1st Department of Cardiology, Hippokration Hospital/Athens Medical School, Athens,
Greece
2. Heart Institute, Hadassah Hebrew University Medical Center, POB 12000, Jerusalem 91120,
Israel.
3. Department of Cardiology, Division of Internal Medicine, University Medical Centre
Ljubljana, Zaloška 7, SI-1525 Ljubljana, Slovenia.
4. Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
5. Second Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece
Description: Patients will undergo a physical exam, coronary angiography and computed
tomography angiography before TAVI. The randomization for direct or non-direct TAVI 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. Access sites for TAVI are: transfemoral, subclavian and transaortic.
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