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

NCT02760771 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2018-02-28

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis

Interventions

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

Sponsors & Collaborators

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Gerhard Schymick, MD · Städtisches Klinikum Karlsruhe

  • David Wendt, PD MD · Westdeutsches Herzzentrum Essen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-06-08
Completion
2017-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760771 on ClinicalTrials.gov