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Completed

NCT Number: NCT01991431

ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiac Surgery dpt., Innsbruck Medical University Hospital, Innsbruck, Austria

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About this study

The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System
  • Compliance with the indications according to the Instructions for Use
  • Written informed consent

Exclusion criteria

  • Presence of contraindications as to the Instructions for Use
  • TAo with concomitant procedure (e.g. Tao + CABG)
  • Participation in the SOURCE XT registry

Treatment and study plan

Primary outcomes

  1. Overall mortality

    Time frame: 30 days

    to determine Overall mortality within 30 days after TAVI

Secondary outcomes

  1. TAVI-related in-Hospital and 30 d mortality

    Time frame: 30 days after TAVI

    see title

  2. complication rates

    Time frame: 30 days after TAVI

    Complication rates as to VARC2

  3. Number of Patients with adverse Events in Relation to Baseline Parameters

    Time frame: 30 days after TAVI

    Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Registry information

Official study title

Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Acronym: ROUTE

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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