NCT02760771

Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often 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 aims 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. There is limited experience for the balloon expandable Edwards THV on the need for predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case series. The investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Detailed description

Aortic valve predilation aims 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, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke. * The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture. The investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
OTHER	with BAV	balloon dilation of the aortic valve prior to implantation of the THV
OTHER	without BAV	no balloon dilation of the aortic valve prior to implantation of the THV

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-06-08
• Completion: 2017-12-01
• First posted: 2016-05-04
• Last updated: 2018-02-28

Locations

1 site across 1 country: Germany