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

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT01991431
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief 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.

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2015-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality	30 days	to determine Overall mortality within 30 days after TAVI

Secondary Outcome Measures

Name	Time	Method
Number of Patients with adverse Events in Relation to Baseline Parameters	30 days after TAVI	Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI
complication rates	30 days after TAVI	Complication rates as to VARC2
TAVI-related in-Hospital and 30 d mortality	30 days after TAVI	see title

Trial Locations

Locations (19)

Policlinico San Matteo/Department of Cardiac Surgery; 🇮🇹 Pavia, Italy

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

CH J. Minjoz - Besancon; 🇫🇷 Besancon, France

Rikshospital Oslo; 🇳🇴 Oslo, Norway

James Cook Hospital - Cardiothoracic Division; 🇬🇧 Middlesborough, United Kingdom

Hopital Cardio-Vasculaire et Pneumologie Louis Pradel; 🇫🇷 Lyon, France

St. Thomas Hospital Cardiothoracic surgery dept; 🇬🇧 London, United Kingdom

Westdeutsches Herzzentrum Essen - Uniklinikum -; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Universitätsklinikum Kiel - Kardiologie u. Angiologie; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Univ. Padova, Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Institut Jacques Cartier Massy; 🇫🇷 Massy, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Rangueil - Toulouse; 🇫🇷 Toulouse, France

Cardiac Surgery dpt., Innsbruck Medical University Hospital; 🇦🇹 Innsbruck, Austria

CHU Bordeaux; 🇫🇷 Bordeaux, France

Division of Cardiology, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Robert-Bosch-Hospital Stuttgart; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Klinika Kardiochirurgii UCK Gdansk; 🇵🇱 Gdansk, Poland

Städt. Klinikum München GmbH Herzchirurgie Bogenhausen; 🇩🇪 München, Bayern, Germany