Aortic Valve StenosisEVERY-TAVINCT02289339
Everyday Practice With Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis, run by LMU Klinikum at 2 sites in Germany.
Trial summary
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- aortic valve prostheses
- Type of treatment
- Medical device
- How many people
- 2,370 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2007to 20 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with aortic valve stenosis suitable for transfemoral transcatheter aortic valve implanation
Who may be able to join
- Aortic stenosis
- Intermediate-to-high risk for surgery
- Heart team decision
Who cannot join
- Contraindication to transfemoral TAVI procedure
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Cardiology Department, Segeberger Kliniken
Bad Segeberg
Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University
Munich
About this study
Official title: Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.
Read the detailed description
The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.
- Conditions
- Aortic Valve Stenosis
- Being tested
- aortic valve prostheses
- 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.
aortic valve prosthesesDevice
Also called CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus
balloon-expandable and self-expandable aortic valve prostheses
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients | all patients undergoing transcatheter aortic valve prostheses implantation Receives: Device: aortic valve prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-TAVI aortic regurgitation
echocardiographicall and angiographycally determined
Measured: 30 days
Secondary outcomes (9)
incidence of bleeding complications
defined according to BARC and VARC-2 classification
Measured: 30 days
mortality
all-cause and cardio/cerebrovascular death
Measured: 30 days
mortality rate
all-cause and cardio/cerebrovascular death
Measured: 2-years
mortality rate
all-cause and cardio/cerebrovascular death
Measured: 5-years
incidence of cerebrovascular events
stroke or TIA
Measured: 30 days
incidence of cerebrovascular events
stroke or TIA
Measured: 2-years
incidence of cerebrovascular events
stroke or TIA
Measured: 5-years
incidence of new pacemaker implantation
pacemaker after TAVI
Measured: 30-day
incidence of new pacemaker implantation
pacemaker after TAVI
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2007
- Primary completion20 Apr 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Julinda Mehilli, LMU Klinikum
- Investigators
- Julinda Mehilli, Prof. MD, Principal investigator, Cardiology Department, Munich University Clinic, Ludwig-Maximilian UniversitySteffen Massberg, Prof. MD, Study chair, Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289339
- Sponsor's protocol ID
- MucS001-14
- Acronym
- EVERY-TAVI
- Status last verified
- Aug 2018
- First submitted
- 8 Nov 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jochheim D, Zadrozny M, Ricard I, Sadry TM, Theiss H, Baquet M, Schwarz F, Bauer A, Khandoga A, Sadoni S, Pichlmaier M, Hausleiter J, Hagl C, Massberg S, Mehilli J. Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry. Int J Cardiol. 2017 Oct 1;244:106-111. doi: 10.1016/j.ijcard.2017.03.003.
PubMed 28784441Mehilli J, Jochheim D, Abdel-Wahab M, Rizas KD, Theiss H, Spenkuch N, Zadrozny M, Baquet M, El-Mawardy M, Sato T, Lange P, Kuppatt C, Greif M, Hausleiter J, Bauer A, Schwarz F, Pichlmaier M, Hagl C, Richardt G, Massberg S. One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. EuroIntervention. 2016 Nov 20;12(10):1298-1304. doi: 10.4244/EIJV12I10A213.
PubMed 27866140Hein-Rothweiler R, Jochheim D, Rizas K, Egger A, Theiss H, Bauer A, Massberg S, Mehilli J. Aortic annulus to left coronary distance as a predictor for persistent left bundle branch block after TAVI. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):E162-E168. doi: 10.1002/ccd.26503. Epub 2016 Apr 1.
PubMed 27038099Jochheim D, Zadrozny M, Theiss H, Baquet M, Maimer-Rodrigues F, Bauer A, Lange P, Greif M, Kupatt C, Hausleiter J, Hagl C, Massberg S, Mehilli J. Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2015 Jun;11(2):214-20. doi: 10.4244/EIJV11I2A40.
PubMed 26093840Jochheim D, Abdel-Wahab M, Mehilli J, Ellert J, Wubken-Kleinfeld N, El-Mawardy M, Pache J, Massberg S, Kastrati A, Richardt G. Significant aortic regurgitation after transfemoral aortic valve implantation: patients' gender as independent risk factor. Minerva Cardioangiol. 2015 Oct;63(5):371-9. Epub 2015 Mar 27.
PubMed 25812583Jochheim D, Schneider VS, Schwarz F, Kupatt C, Lange P, Reiser M, Massberg S, Gutierrez-Chico JL, Mehilli J, Becker HC. Contrast-induced acute kidney injury after computed tomography prior to transcatheter aortic valve implantation. Clin Radiol. 2014 Oct;69(10):1034-8. doi: 10.1016/j.crad.2014.05.106. Epub 2014 Jul 10.
PubMed 25017451
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers
- ClinicalTrials.gov ID
- NCT02289339
- Acronym / sponsor ID
- EVERY-TAVI / MucS001-14
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,370 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 13 Nov 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.
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.
Detailed description
The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | Device: aortic valve prosthesesall patients undergoing transcatheter aortic valve prostheses implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with aortic valve stenosis suitable for transfemoral transcatheter aortic valve implanation
Key inclusion criteria (3 listed)
- Aortic stenosis
- Intermediate-to-high risk for surgery
- Heart team decision
Key exclusion criteria (1 listed)
- Contraindication to transfemoral TAVI procedure
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 |
|---|---|---|
| aortic valve prosthesesAlso: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotusballoon-expandable and self-expandable aortic valve prostheses | Device | TAVI patients |
Primary outcome
incidence of post-TAVI aortic regurgitation
Time frame: 30 days
echocardiographicall and angiographycally determined
9 secondary outcomes
incidence of bleeding complications
Time frame: 30 days
mortality
Time frame: 30 days
mortality rate
Time frame: 2-years
mortality rate
Time frame: 5-years
incidence of cerebrovascular events
Time frame: 30 days
incidence of cerebrovascular events
Time frame: 2-years
incidence of cerebrovascular events
Time frame: 5-years
incidence of new pacemaker implantation
Time frame: 30-day
incidence of new pacemaker implantation
Time frame: 1-year
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 13 Aug 2018.
- Results publication: PubMed 28784441Jochheim D, Zadrozny M, Ricard I, Sadry TM, Theiss H, Baquet M, Schwarz F, Bauer A, Khandoga A, Sadoni S, Pichlmaier M, Hausleiter J, Hagl C, Massberg S, Mehilli J. Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry. Int J Cardiol. 2017 Oct 1;244:106-111. doi: 10.1016/j.ijcard.2017.03.003.
- Results publication: PubMed 27866140Mehilli J, Jochheim D, Abdel-Wahab M, Rizas KD, Theiss H, Spenkuch N, Zadrozny M, Baquet M, El-Mawardy M, Sato T, Lange P, Kuppatt C, Greif M, Hausleiter J, Bauer A, Schwarz F, Pichlmaier M, Hagl C, Richardt G, Massberg S. One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. EuroIntervention. 2016 Nov 20;12(10):1298-1304. doi: 10.4244/EIJV12I10A213.
- Results publication: PubMed 27038099Hein-Rothweiler R, Jochheim D, Rizas K, Egger A, Theiss H, Bauer A, Massberg S, Mehilli J. Aortic annulus to left coronary distance as a predictor for persistent left bundle branch block after TAVI. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):E162-E168. doi: 10.1002/ccd.26503. Epub 2016 Apr 1.
- Results publication: PubMed 26093840Jochheim D, Zadrozny M, Theiss H, Baquet M, Maimer-Rodrigues F, Bauer A, Lange P, Greif M, Kupatt C, Hausleiter J, Hagl C, Massberg S, Mehilli J. Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2015 Jun;11(2):214-20. doi: 10.4244/EIJV11I2A40.
- Results publication: PubMed 25812583Jochheim D, Abdel-Wahab M, Mehilli J, Ellert J, Wubken-Kleinfeld N, El-Mawardy M, Pache J, Massberg S, Kastrati A, Richardt G. Significant aortic regurgitation after transfemoral aortic valve implantation: patients' gender as independent risk factor. Minerva Cardioangiol. 2015 Oct;63(5):371-9. Epub 2015 Mar 27.
- Results publication: PubMed 25017451Jochheim D, Schneider VS, Schwarz F, Kupatt C, Lange P, Reiser M, Massberg S, Gutierrez-Chico JL, Mehilli J, Becker HC. Contrast-induced acute kidney injury after computed tomography prior to transcatheter aortic valve implantation. Clin Radiol. 2014 Oct;69(10):1034-8. doi: 10.1016/j.crad.2014.05.106. Epub 2014 Jul 10.
- Individual participant dataSharing planned: Undecided
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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.
Julinda Mehilli, Prof. MD principal investigator
Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
Steffen Massberg, Prof. MD study chair
Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by LMU Klinikum at 2 sites 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 3 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
incidence of post-TAVI aortic regurgitation (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 NCT02289339, which also lists 6 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 13 Aug 2018.