Aortic Valve StenosisNCT05015452
The Leipzig TAVI Registry
An observational study of Aortic Valve Stenosis, run by Helios Health Institute GmbH at 1 site in Germany.
Trial summary
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany 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?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All comers patient population treated with TAVI
Who may be able to join
- All patients treated with TAVI
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Thiele, MD contact
Germany1 site, 1 recruiting
- Recruiting
Herzzentrum Leipzig
Leipzig
Mohamed Abdel-Wahab, MD
About this study
Official title: An Observational Follow-up Assessment of Transcatheter Aortic Valve Implantation in Leipzig
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany
Read the detailed description
A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation
- 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.
Transcatheter Aortic Valve ImplantationDevice
Interventional replacement of the aortic valve
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Cardiovascular and not cardiovascular death
- identify the current incidence of periprocedural complications.
- identification of risk groups
- description of the long-term outcome with special attention to the durability of the different prostheses
Measured: Up to 10 years
Secondary outcomes (1)
Structural valve deterioration
Transposthetic mean pressure gradient ≥ 40mmHg and/or ≥20mmHg rise from baseline OR severe intraprosthetic aortic regurgitation
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015452
- Sponsor's protocol ID
- 2020-0089
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abdelhafez A, Lankisch N, Iannopollo G, Dumpies O, Rotta Detto Loria J, Richter I, Majunke N, Feistritzer HJ, Gohmann R, Desch S, Noack T, Thiele H, Abdel-Wahab M. CT-Based Risk Stratification of Coronary Obstruction During TAVR: Clinical Utility and a New Volumetric Parameter. JACC Cardiovasc Interv. 2026 Jun 8;19(11):1406-1419. doi: 10.1016/j.jcin.2026.04.015.
PubMed 42264632Abdel-Wahab M, Kitamura M, Fitzgerald SJ, Dumpies O, Wilde J, Gohmann RF, Majunke N, Gutberlet M, Kiefer P, Noack T, Lurz P, Desch S, Frawley C, Ward K, Borger MA, Holzhey D, Thiele H. Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve. Circ Cardiovasc Interv. 2022 Jul;15(7):e011993. doi: 10.1161/CIRCINTERVENTIONS.122.011993. Epub 2022 Jul 1. No abstract available.
PubMed 35775417
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-up Assessment of Transcatheter Aortic Valve Implantation in Leipzig
- ClinicalTrials.gov ID
- NCT05015452
- Acronym / sponsor ID
- 2020-0089
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Aug 2021 (actual)
- 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.
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany
Detailed description
A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All comers patient population treated with TAVI
Key inclusion criteria (1 listed)
- All patients treated with TAVI
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationInterventional replacement of the aortic valve | Device | – |
Primary outcome
Mortality
Time frame: Up to 10 years
Cardiovascular and not cardiovascular death 1. identify the current incidence of periprocedural complications. 2. identification of risk groups 3. description of the long-term outcome with special attention to the durability of the different prostheses
1 secondary outcome
Structural valve deterioration
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 42264632Abdelhafez A, Lankisch N, Iannopollo G, Dumpies O, Rotta Detto Loria J, Richter I, Majunke N, Feistritzer HJ, Gohmann R, Desch S, Noack T, Thiele H, Abdel-Wahab M. CT-Based Risk Stratification of Coronary Obstruction During TAVR: Clinical Utility and a New Volumetric Parameter. JACC Cardiovasc Interv. 2026 Jun 8;19(11):1406-1419. doi: 10.1016/j.jcin.2026.04.015.
- Derived from this study: PubMed 35775417Abdel-Wahab M, Kitamura M, Fitzgerald SJ, Dumpies O, Wilde J, Gohmann RF, Majunke N, Gutberlet M, Kiefer P, Noack T, Lurz P, Desch S, Frawley C, Ward K, Borger MA, Holzhey D, Thiele H. Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve. Circ Cardiovasc Interv. 2022 Jul;15(7):e011993. doi: 10.1161/CIRCINTERVENTIONS.122.011993. Epub 2022 Jul 1. No abstract available.
- 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.
Holger Thiele, MD contact
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, run by Helios Health Institute GmbH 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 1 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdel-Wahab, MD (+49 341 865 1428, mohamed.bdel-wahab@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Up to 10 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 NCT05015452, which also lists 2 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 9 Oct 2024.