NCT02127580

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

Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry. We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Detailed description

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 coronary, cerebral, and renal ischemia. * In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality. * BAV has been identified as a major source of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke. * The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
PROCEDURE	BAV
PROCEDURE	without BAV

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2014-04-30
• Last updated: 2018-04-27

Locations

7 sites across 1 country: Germany