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NCT01991431 Clinical Trial

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

Aortic Stenosis Clinical Trial

— ROUTE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01991431
Other study ID # U1111-1149-9900
Secondary ID
Status Completed
Phase N/A
First received November 6, 2013
Last updated February 20, 2017
Start date February 2013
Est. completion date November 2016

Study information
Verified date February 2017
Source Institut für Pharmakologie und Präventive Medizin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 303
Est. completion date November 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Cardiac Surgery dpt., Innsbruck Medical University Hospital Innsbruck
Finland Division of Cardiology, Helsinki University Central Hospital Helsinki
France CH J. Minjoz - Besancon Besancon
France CHU Bordeaux Bordeaux
France Hopital Cardio-Vasculaire et Pneumologie Louis Pradel Lyon
France Institut Jacques Cartier Massy Massy
France CHU Rouen Rouen
France CHU Rangueil - Toulouse Toulouse
Germany Westdeutsches Herzzentrum Essen - Uniklinikum - Essen Nordrhein-Westfalen
Germany Universitätsklinikum Kiel - Kardiologie u. Angiologie Kiel Schleswig-Holstein
Germany Städt. Klinikum München GmbH Herzchirurgie Bogenhausen München Bayern
Germany Robert-Bosch-Hospital Stuttgart Stuttgart Baden-Württemberg
Italy Univ. Padova, Azienda Ospedaliera di Padova Padova
Italy Policlinico San Matteo/Department of Cardiac Surgery Pavia
Netherlands Academisch Medisch Centrum Amsterdam
Norway Rikshospital Oslo Oslo
Poland Klinika Kardiochirurgii UCK Gdansk Gdansk
United Kingdom St. Thomas Hospital Cardiothoracic surgery dept London
United Kingdom James Cook Hospital - Cardiothoracic Division Middlesborough

Sponsors (1)
Lead Sponsor Collaborator
Institut für Pharmakologie und Präventive Medizin

Countries where clinical trial is conducted

Austria,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall mortality to determine Overall mortality within 30 days after TAVI 30 days
Secondary TAVI-related in-Hospital and 30 d mortality see title 30 days after TAVI
Secondary complication rates Complication rates as to VARC2 30 days after TAVI
Secondary Number of Patients with adverse Events in Relation to Baseline Parameters Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI 30 days after TAVI
See also
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Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01676727 - ADVANCE Direct Aortic Study
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A

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