Aortic Valve StenosisTAVINCT02815514
German TAVI-Register
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Stiftung Institut fuer Herzinfarktforschung at 1 site in Germany.
Trial summary
The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2016
- 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: All patients with significant aortic valve stenosis, treated with aortic valve procedures.
Who may be able to join
- patients with aortic stenosis (degree III) who received one of the following therapies:
- transapical operative aortic valve implantation
- operative aortic valve implantation
- percutaneous aortic valve implantation
- balloon valvuloplasty
Who cannot join
- missing signed informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut fur Herzinfarktforschung Ludwigshafen
Ludwigshafen, RPF, 67063
About this study
Official title: Deutsches TAVI-Register
The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.
Read the detailed description
Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies:
- Percutaneous transfemoral aortic valve replacement
- Percutaneous aortic valve replacement transapical
- Percutaneous aortic valve replacement transaortic
- Aortic valve balloon valvuloplasty
- Surgical aortic valve replacement
- Conservative treatment
- Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies
- Documentation of operational risk and quality of life
- Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions
- Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status)
- Documentation of discharge medication and the length of hospital stay
- Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- aortic valve stenosis, aortic valve insufficiency, transapical aortic valve implantation, aortic valve replacement, percutaneous aortic valve replacement, aortic valve valvuloplasty
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
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 |
|---|---|---|
| Aortic valve procedures | 1. percutaneous transfemoral aortic valve implantation 2. percutaneous transapical aortic valve implantation 3. percutaneous transaortic aortic valve implantation 4. aortic valve valvuloplasty 5. surgical aortic valve replacement 6. conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 5 years
Secondary outcomes (8)
Short- and long-term results of the documented therapies
Documentation of procedural results and clinical short-and long-term results of the documented therapies
Measured: 5 years
Details on operational risk
Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.
Measured: up to four weeks
Details of performed procedures
Documentation of the indications, the technical implementation of the procedures and success of the intervention and of possible hospital reinterventions.
Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.
Measured: up to four weeks
Complications during hospital stay
Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status).
Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.
Measured: up to four weeks
Details of hospital stay
Documentation of e.g. drug treatment, discharge medication and the length of hospital stay.
Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.
Measured: up to four weeks
Serious long-term complications
Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions
Measured: 5 years
Quality of life
Measured: 5 years
Drug treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Senges, MD, Principal investigator, Stiftung Insitut fuer Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815514
- Sponsor's protocol ID
- TAVI
- Acronym
- TAVI
- Status last verified
- Jun 2016
- First submitted
- 22 Mar 2011
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deutsches TAVI-Register
- ClinicalTrials.gov ID
- NCT02815514
- Acronym / sponsor ID
- TAVI / TAVI
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- aortic valve stenosis, aortic valve insufficiency, transapical aortic valve implantation, aortic valve replacement, percutaneous aortic valve replacement, aortic valve valvuloplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jun 2016 (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 TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.
Detailed description
Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies:
- Percutaneous transfemoral aortic valve replacement
- Percutaneous aortic valve replacement transapical
- Percutaneous aortic valve replacement transaortic
- Aortic valve balloon valvuloplasty
- Surgical aortic valve replacement
- Conservative treatment
- Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies
- Documentation of operational risk and quality of life
- Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions
- Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status)
- Documentation of discharge medication and the length of hospital stay
- Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic valve procedures | – | –1. percutaneous transfemoral aortic valve implantation 2. percutaneous transapical aortic valve implantation 3. percutaneous transaortic aortic valve implantation 4. aortic valve valvuloplasty 5. surgical aortic valve replacement 6. conservative treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with significant aortic valve stenosis, treated with aortic valve procedures.
Key inclusion criteria (5 listed)
- transapical operative aortic valve implantation
- operative aortic valve implantation
- percutaneous aortic valve implantation
- balloon valvuloplasty
Key exclusion criteria (1 listed)
- missing signed 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.
Primary outcome
All cause mortality
Time frame: 5 years
8 secondary outcomes
Short- and long-term results of the documented therapies
Time frame: 5 years
Details on operational risk
Time frame: up to four weeks
Details of performed procedures
Time frame: up to four weeks
Complications during hospital stay
Time frame: up to four weeks
Details of hospital stay
Time frame: up to four weeks
Serious long-term complications
Time frame: 5 years
Quality of life
Time frame: 5 years
Drug treatment
Time frame: 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 13 Apr 2017.
- 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.
Jochen Senges, MD principal investigator
Stiftung Insitut fuer Herzinfarktforschung
1 site 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 and Aortic Valve Insufficiency, run by Stiftung Institut fuer Herzinfarktforschung 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 5 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 Apr 2017. 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?
All cause mortality (time frame: 5 years). 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 13 Apr 2017.