NCT01991431

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
9 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

November 6, 2013

Last Update Submit

February 20, 2017

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    to determine Overall mortality within 30 days after TAVI

    30 days

Secondary Outcomes (3)

  • TAVI-related in-Hospital and 30 d mortality

    30 days after TAVI

  • complication rates

    30 days after TAVI

  • Number of Patients with adverse Events in Relation to Baseline Parameters

    30 days after TAVI

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Cardiac Surgery dpt., Innsbruck Medical University Hospital

Innsbruck, Austria

Location

Division of Cardiology, Helsinki University Central Hospital

Helsinki, Finland

Location

CH J. Minjoz - Besancon

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33604, France

Location

Hopital Cardio-Vasculaire et Pneumologie Louis Pradel

Lyon, France

Location

Institut Jacques Cartier Massy

Massy, 91349, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHU Rangueil - Toulouse

Toulouse, 31059, France

Location

Robert-Bosch-Hospital Stuttgart

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Städt. Klinikum München GmbH Herzchirurgie Bogenhausen

München, Bavaria, 81925, Germany

Location

Westdeutsches Herzzentrum Essen - Uniklinikum -

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitätsklinikum Kiel - Kardiologie u. Angiologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Univ. Padova, Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Policlinico San Matteo/Department of Cardiac Surgery

Pavia, Italy

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

Rikshospital Oslo

Oslo, Norway

Location

Klinika Kardiochirurgii UCK Gdansk

Gdansk, Poland

Location

St. Thomas Hospital Cardiothoracic surgery dept

London, United Kingdom

Location

James Cook Hospital - Cardiothoracic Division

Middlesbrough, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 30346515DERIVED

  • 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.

    PMID: 28582580DERIVED

  • 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.

    PMID: 28369303DERIVED

  • 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.

    PMID: 27609256DERIVED

  • 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.

    PMID: 25361564DERIVED

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Vinayak Bapat, MD

    St. Thomas' Hospital, London, UK

    PRINCIPAL INVESTIGATOR

  • Mauro Romano, MD

    Institut Hospitalier Jacques Cartier, Massy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 25, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

GB(2)NO(1)FR(6)PL(1)DE(4)FI(1)IT(2)NL(1)AU(1)