Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve

Launched by INSTITUT FÜR PHARMAKOLOGIE UND PRÄVENTIVE MEDIZIN · Apr 29, 2014

Keywords

ClinConnect Summary

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is usually performed under rapid right ventricular pacing (burst \>180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation is aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:

* Functional cardiac arrest induced by rapid pacing leads to transient corona...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with an indication for TAVI as to the Edwards THV IFU
• • Eligible for TABI with AND without BAV
• • Signed informed consent
• Exclusion Criteria:
• • Logistic EuroSCORE I \>50%
• • Mitral or tricuspid valvular insufficiency (\> grade II)
• • Previous aortic valve replacement
• • Uncontrolled atrial fibrillation
• • Left ventricular or atrial thrombus by echocardiography
• • Recent cerebrovascular event (within the last 3 months)
• • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

Trial Officials