Aortic StenosisROUTENCT01991431
ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
An observational study of Aortic Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 19 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 303 participants
- Where
- 19 sitesin 9 countries
- Study dates
- Feb 2013to Nov 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Presence of contraindications as to the Instructions for Use
- TAo with concomitant procedure (e.g. Tao + CABG)
- Participation in the SOURCE XT registry
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
France6 sites
CH J. Minjoz - Besancon
Besançon, 25030
CHU Bordeaux
Bordeaux, 33604
Hopital Cardio-Vasculaire et Pneumologie Louis Pradel
Lyon
Institut Jacques Cartier Massy
Massy, 91349
CHU Rouen
Rouen, 76031
CHU Rangueil - Toulouse
Toulouse, 31059
Germany4 sites
Westdeutsches Herzzentrum Essen - Uniklinikum -
Essen, North Rhine-Westphalia, 45122
Universitätsklinikum Kiel - Kardiologie u. Angiologie
Kiel, Schleswig-Holstein, 24105
Städt. Klinikum München GmbH Herzchirurgie Bogenhausen
München, Bavaria, 81925
Robert-Bosch-Hospital Stuttgart
Stuttgart, Baden-Wurttemberg, 70376
Italy2 sites
Univ. Padova, Azienda Ospedaliera di Padova
Padova, 35128
Policlinico San Matteo/Department of Cardiac Surgery
Pavia
United Kingdom2 sites
St. Thomas Hospital Cardiothoracic surgery dept
London
James Cook Hospital - Cardiothoracic Division
Middlesbrough
Austria1 site
Cardiac Surgery dpt., Innsbruck Medical University Hospital
Innsbruck
Finland1 site
Division of Cardiology, Helsinki University Central Hospital
Helsinki
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
to determine Overall mortality within 30 days after TAVI
Measured: 30 days
Secondary outcomes (3)
TAVI-related in-Hospital and 30 d mortality
see title
Measured: 30 days after TAVI
complication rates
Complication rates as to VARC2
Measured: 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
Measured: 30 days after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vinayak Bapat, MD, Principal investigator, St. Thomas' Hospital, London, UKMauro Romano, MD, Principal investigator, Institut Hospitalier Jacques Cartier, Massy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991431
- Sponsor's protocol ID
- U1111-1149-9900
- Acronym
- ROUTE
- Status last verified
- Feb 2017
- First submitted
- 6 Nov 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30346515Romano 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.
PubMed 28582580Bonaros 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.
PubMed 28369303Bapat 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.
PubMed 27609256Bramlage 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.
PubMed 25361564
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
- ClinicalTrials.gov ID
- NCT01991431
- Acronym / sponsor ID
- ROUTE / U1111-1149-9900
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Feb 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of contraindications as to the Instructions for Use
- TAo with concomitant procedure (e.g. Tao + CABG)
- Participation in the SOURCE XT registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall mortality
Time frame: 30 days
to determine Overall mortality within 30 days after TAVI
3 secondary outcomes
TAVI-related in-Hospital and 30 d mortality
Time frame: 30 days after TAVI
complication rates
Time frame: 30 days after TAVI
Number of Patients with adverse Events in Relation to Baseline Parameters
Time frame: 30 days after TAVI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 30346515Cocchieri 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.
- Derived from this study: PubMed 28582580Romano 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.
- Derived from this study: PubMed 28369303Bonaros 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.
- Derived from this study: PubMed 27609256Bapat 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.
- Derived from this study: PubMed 25361564Bramlage 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.
- Design paperLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinayak Bapat, MD principal investigator
St. Thomas' Hospital, London, UK
Mauro Romano, MD principal investigator
Institut Hospitalier Jacques Cartier, Massy, France
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 19 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, Italy, United Kingdom, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991431, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.