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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991431
First Posted: November 25, 2013
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
  Purpose
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.

Condition
Aortic Stenosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Resource links provided by NLM:


Further study details as provided by Institut für Pharmakologie und Präventive Medizin:

Primary Outcome Measures:
  • Overall mortality [ Time Frame: 30 days ]
    to determine Overall mortality within 30 days after TAVI


Secondary Outcome Measures:
  • TAVI-related in-Hospital and 30 d mortality [ Time Frame: 30 days after TAVI ]
    see title

  • complication rates [ Time Frame: 30 days after TAVI ]
    Complication rates as to VARC2

  • 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


Enrollment: 303
Actual Study Start Date: February 2013
Study Completion Date: November 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
TAVI
All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991431


Locations
Austria
Cardiac Surgery dpt., Innsbruck Medical University Hospital
Innsbruck, Austria
Finland
Division of Cardiology, Helsinki University Central Hospital
Helsinki, Finland
France
CH J. Minjoz - Besancon
Besancon, France, 25030
CHU Bordeaux
Bordeaux, France, 33604
Hopital Cardio-Vasculaire et Pneumologie Louis Pradel
Lyon, France
Institut Jacques Cartier Massy
Massy, France, 91349
CHU Rouen
Rouen, France, 76031
CHU Rangueil - Toulouse
Toulouse, France, 31059
Germany
Robert-Bosch-Hospital Stuttgart
Stuttgart, Baden-Württemberg, Germany, 70376
Städt. Klinikum München GmbH Herzchirurgie Bogenhausen
München, Bayern, Germany, 81925
Westdeutsches Herzzentrum Essen - Uniklinikum -
Essen, Nordrhein-Westfalen, Germany, 45122
Universitätsklinikum Kiel - Kardiologie u. Angiologie
Kiel, Schleswig-Holstein, Germany, 24105
Italy
Univ. Padova, Azienda Ospedaliera di Padova
Padova, Italy, 35128
Policlinico San Matteo/Department of Cardiac Surgery
Pavia, Italy
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Norway
Rikshospital Oslo
Oslo, Norway
Poland
Klinika Kardiochirurgii UCK Gdansk
Gdansk, Poland
United Kingdom
St. Thomas Hospital Cardiothoracic surgery dept
London, United Kingdom
James Cook Hospital - Cardiothoracic Division
Middlesborough, United Kingdom
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
Principal Investigator: Vinayak Bapat, MD St. Thomas' Hospital, London, UK
Principal Investigator: Mauro Romano, MD Institut Hospitalier Jacques Cartier, Massy, France
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT01991431     History of Changes
Other Study ID Numbers: U1111-1149-9900
First Submitted: November 6, 2013
First Posted: November 25, 2013
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction