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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis

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 Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	to determine Overall mortality within 30 days after TAVI	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAVI-related in-Hospital and 30 d mortality	see title	30 days after TAVI
complication rates	Complication rates as to VARC2	30 days after TAVI
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.
• Romano M, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Deutsch C, Bramlage P, Thoenes M, Bapat V. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. Interact Cardiovasc Thorac Surg. 2017 Nov 1;25(5):757-764. doi: 10.1093/icvts/ivx159.
• Bonaros N, Petzina R, Cocchieri R, Jagielak D, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Bapat V, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Kofler M, Bramlage P, Deutsch C, Thoenes M, Frank D, Romano M. Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. Eur J Cardiothorac Surg. 2017 May 1;51(5):919-926. doi: 10.1093/ejcts/ezw406.
• Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Baumbach H, Bramlage P, Deutsch C, Thoenes M, Romano M. Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1815-22. doi: 10.1016/j.jcin.2016.06.031.
• Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V. Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry. BMC Cardiovasc Disord. 2014 Nov 1;14:152. doi: 10.1186/1471-2261-14-152.

Helpful Links

• Design paper

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: U1111-1149-9900