NCT02448927

The preDIlatation in tRanscathEter aortiC Valve implanTation Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	balloon aortic valvuloplasty
DEVICE	Transcatheter Aortic Valve Implantation

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-02
• Completion: 2018-05-02
• First posted: 2015-05-20
• Last updated: 2019-09-06

Locations

4 sites across 2 countries: Greece, Israel