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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
170
First Department of Cardiology, University of Athens
Athens, Attica, Greece
Department of Cardiology, Onassis Cardiac Surgery Center
Athens, Greece
Second Department of Cardiology, University Hospital of Ioannina
Ioannina, Greece
Heart Institute Hadassah Hebrew University Medical Center
Jerusalem, Israel
Device success
Device success, as designated by the VARC-2 criteria.
Time frame: 30 days
Death
Death during the hospitalization of the patient, as designated by the VARC-2 criteria.
Time frame: 30 days
Cerebrovascular accident
Cerebrovascular accident during and after the hospitalization of the patient, as designated by the VARC-2 criteria.
Time frame: 30 days and 1 year
New pacemaker implantation
New pacemaker implantation during the hospitalization of the patient, as designated by the VARC-2 criteria.
Time frame: 30 days
Vascular complications
Vascular complications during the hospitalization of the patient, as designated by the VARC-2 criteria.
Time frame: 30 days
Mortality
Death after discharge of the patient, as designated by the VARC-2 criteria.
Time frame: after 30 days and at 1 year
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