Aortic Valve StenosisCSI-TAVRNCT02162069
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
A study testing CE certified transcatheter ( aortic valve replacement) in people with Aortic Valve Stenosis, run by University of Ulm at 1 site in Germany.
Trial summary
To evaluate the long-term results after transcatheter aortic valve replacement 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?
- CE certified transcatheter ( aortic valve replacement)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- aortic valve stenosis
- transcatheter aortic valve replacement
Who cannot join
- no written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term results after transcatheter aortic valve replacement
Read the detailed description
Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.
- Conditions
- Aortic Valve Stenosis
- Being tested
- CE certified transcatheter ( aortic valve replacement)
- 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.
CE certified transcatheter ( aortic valve replacement)Device
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.
| Study group | Role | What they receive |
|---|---|---|
| transcatheter aortic valve replacement | Experimental | Patients receive transcatheter aortic valve replacement. Receives: Device: CE certified transcatheter ( aortic valve replacement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cerebral and cardiac events.
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TAVR
- Masking
- None (open label)
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Wohrle, University of Ulm
- Investigators
- Jochen Wöhrle, MD, Principal investigator, University of Ulm, Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162069
- Sponsor's protocol ID
- CSI TAVR 1.0
- Acronym
- CSI-TAVR
- Status last verified
- Apr 2020
- First submitted
- 7 Jun 2014
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13.
PubMed 28917515Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
PubMed 30590554Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.
PubMed 35576863Seeger J, Gonska B, Rottbauer W, Wohrle J. New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome. Cardiovasc Interv Ther. 2018 Jul;33(3):247-255. doi: 10.1007/s12928-017-0477-6. Epub 2017 Jun 22.
PubMed 28643214Seeger J, Gonska B, Rottbauer W, Wohrle J. Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jun;10(6):e004670. doi: 10.1161/CIRCINTERVENTIONS.116.004670.
PubMed 28566290Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.
PubMed 27561160Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. doi: 10.1371/journal.pone.0151247. eCollection 2016.
PubMed 27003573
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02162069
- Acronym / sponsor ID
- CSI-TAVR / CSI TAVR 1.0
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Jun 2014 (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.
To evaluate the long-term results after transcatheter aortic valve replacement
Detailed description
Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TAVR
| Arm | Type | Receives |
|---|---|---|
| transcatheter aortic valve replacement | Experimental | Device: CE certified transcatheter ( aortic valve replacement)Patients receive transcatheter aortic valve replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aortic valve stenosis
- transcatheter aortic valve replacement
Key exclusion criteria (1 listed)
- no written informed consent
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 |
|---|---|---|
| CE certified transcatheter ( aortic valve replacement)Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves. | Device | transcatheter aortic valve replacement |
Primary outcome
Major adverse cerebral and cardiac events.
Time frame: 1-5 years
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 28 Apr 2020.
- Background: PubMed 28917515Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13.
- Results publication: PubMed 30590554Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
- Derived from this study: PubMed 35576863Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.
- Derived from this study: PubMed 28643214Seeger J, Gonska B, Rottbauer W, Wohrle J. New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome. Cardiovasc Interv Ther. 2018 Jul;33(3):247-255. doi: 10.1007/s12928-017-0477-6. Epub 2017 Jun 22.
- Derived from this study: PubMed 28566290Seeger J, Gonska B, Rottbauer W, Wohrle J. Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jun;10(6):e004670. doi: 10.1161/CIRCINTERVENTIONS.116.004670.
- Derived from this study: PubMed 27561160Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.
- Derived from this study: PubMed 27003573Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. doi: 10.1371/journal.pone.0151247. eCollection 2016.
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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.
Jochen Wöhrle, MD principal investigator
University of Ulm, Ulm, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE certified transcatheter ( aortic valve replacement) in people with Aortic Valve Stenosis, run by University of Ulm at 1 site in Germany.
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 2 inclusion and 1 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Major adverse cerebral and cardiac events. (time frame: 1-5 years). 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 NCT02162069, which also lists 7 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 28 Apr 2020.