Aortic Valve StenosisNCT01238835
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A study testing SAPIEN XT™ Transapical aortic valve replacement in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 20 sites in 4 countries.
Trial summary
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- SAPIEN XT™ Transapical aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Sep 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- EuroSCORE of ≥ 15 %
- Severe senile degenerative aortic valve stenosis
- Symptomatic aortic valve stenosis
- Informed consent
- Compliance
Who cannot join
- Logistic Euroscore > 40 %
- Evidence of an acute myocardial infarction
- Congenital unicuspid or congenital bicuspid valve/ non-calcified
- Mixed aortic valve disease
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Germany16 sites
Herz-Und Gefasszentrum Bad Bevensen
Bad Bevensen, 29549
Kerckhoff-Klinik
Bad Nauheim, 61231
Herz-und-Gefass Klinik
Bad Neustadt an der Saale, 97616
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Schüchtermann-Klinik
Bad Rothenfelde, 49214
Heart Center University Cologne
Cologne, 50924
Herzzentrum Dresden GmbH
Dresden, 01307
University Clinic Erlangen
Erlangen, 91054
University Hospital Essen, West German Heart Center
Essen, 45122
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Cardiac Surgery Karlsruhe
Karlsruhe, 76185
Heart Center Leipzig
Leipzig, 04829
German Heart Center Munich
Munich, 80636
University Hospital Munich-Grosshadern
Munich, 81377
Hospital Munich-Bogenhausen
Munich, 81925
Robert-Bosch-Krankenhaus
Stuttgart, 70376
United Kingdom2 sites
St. Thomas' Hospital - NHS Trust
London, SE1 7EH
King's College Hospital
London, SE5 9RS
Austria1 site
Medizinische Universitat Wien Univ.Klinik f.Chirurgie
Vienna, 1019
About this study
Official title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.
Read the detailed description
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.
Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.
- Conditions
- Aortic Valve Stenosis
- Being tested
- SAPIEN XT™ Transapical aortic valve replacement
- Keywords
- Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN XT™ Transapical aortic valve replacementDevice
Also called Sapien XT, Next generation Ascendra delivery system inclusive accessory
Transcatheter aortic valve implantation via the transapical approach
| Study group | Role | What they receive |
|---|---|---|
| TAVR-TA | Experimental | Transcatheter valve replacement with transapical access Receives: Device: SAPIEN XT™ Transapical aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths
Number of death at 30-days from the index procedure.
Measured: 30 days
Secondary outcomes (1)
Number of Participants With a Stroke
Total Number of Participants with a Stroke.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Thomas Walther, Principal investigator, Kerckhoff KlinikDr. Olaf Wendler, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238835
- Sponsor's protocol ID
- 2009-06
- Status last verified
- Oct 2020
- First submitted
- 26 Jan 2010
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
- ClinicalTrials.gov ID
- NCT01238835
- Acronym / sponsor ID
- 2009-06
- Conditions
- Aortic Valve Stenosis
- Keywords
- Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2009 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.
Detailed description
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.
Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR-TA | Experimental | Device: SAPIEN XT™ Transapical aortic valve replacementTranscatheter valve replacement with transapical access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- EuroSCORE of ≥ 15 %
- Severe senile degenerative aortic valve stenosis
- Symptomatic aortic valve stenosis
- Informed consent
- Compliance
Key exclusion criteria (4 listed)
- Logistic Euroscore > 40 %
- Evidence of an acute myocardial infarction
- Congenital unicuspid or congenital bicuspid valve/ non-calcified
- Mixed aortic valve disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAPIEN XT™ Transapical aortic valve replacementAlso: Sapien XT, Next generation Ascendra delivery system inclusive accessoryTranscatheter aortic valve implantation via the transapical approach | Device | TAVR-TA |
Primary outcome
Number of Deaths
Time frame: 30 days
Number of death at 30-days from the index procedure.
1 secondary outcome
Number of Participants With a Stroke
Time frame: 30-days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Prof. Dr. Thomas Walther principal investigator
Kerckhoff Klinik
Dr. Olaf Wendler principal investigator
King's College London
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAPIEN XT™ Transapical aortic valve replacement in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 20 sites in 4 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 5 inclusion and 4 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, United Kingdom, Austria, France. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Deaths (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2020.