Aortic Valve StenosisPOST-TAVINCT03192774
The Prospective Segeberg TAVI Registry
An observational study of Aortic Valve Stenosis, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Dec 2032
- 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 to 100 years
- 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.
Mohamed Abdel-Wahab, MD contact
Ralph Toelg contact
Germany1 site, 1 recruiting
- Recruiting
Heart Center, Segeberger Kliniken
Bad Segeberg, 23795
Mohamed Abdel-Wahab, MD
About this study
Official title: A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany
Read the detailed description
A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 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
Measured: Up to 10 years
Secondary outcomes (1)
Structural valve deterioration
Transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg 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 Jun 2017
- Study startSep 2007
- Primary completionDec 2022 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Segeberger Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gert Richardt, MD, Study chair, Heart Center, Segeberger KlinikenMohamed Abdel-Wahab, MD, Principal investigator, Heart Center, Segeberger Kliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192774
- Sponsor's protocol ID
- SK 109 -- 168/11
- Acronym
- POST-TAVI
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2017
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Amoey D, Samy M, Elbasha K, Alali A, Landt M, Kurniadi A, Nef H, Tolg R, Richardt G, Mankerious N. Predictors and Outcomes of Inappropriate Dosing of Direct Oral Anticoagulants in Patients Receiving Transcatheter Aortic Valve Implantation. Cardiol Ther. 2024 Dec;13(4):761-773. doi: 10.1007/s40119-024-00387-0. Epub 2024 Nov 4.
PubMed 39495243Samy M, Landt M, Mankerious N, Kurniadi A, Alotaibi S, Toelg R, Abdel-Wahab M, Nef H, Allali A, Richardt G, Elbasha K. ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation. Catheter Cardiovasc Interv. 2024 Nov;104(6):1251-1259. doi: 10.1002/ccd.31259. Epub 2024 Oct 8.
PubMed 39378384Alotaibi S, Elbasha K, Landt M, Kaur J, Kurniadi A, Abdel-Wahab M, Toelg R, Richardt G, Allali A. Prognostic Value of HFA-PEFF Score in Patients Undergoing Transcatheter Aortic Valve Implantation. Cureus. 2022 Jul 22;14(7):e27152. doi: 10.7759/cureus.27152. eCollection 2022 Jul.
PubMed 36017287Abdelghani M, Mankerious N, Landt M, Toelg R, Abdel-Wahab M, Richardt G. Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium. Am J Cardiol. 2020 Mar 15;125(6):931-940. doi: 10.1016/j.amjcard.2019.12.022. Epub 2019 Dec 27.
PubMed 31959428
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg
- ClinicalTrials.gov ID
- NCT03192774
- Acronym / sponsor ID
- POST-TAVI / SK 109 -- 168/11
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Segeberger Kliniken GmbHUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 20 Jun 2017 (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, Bad Segeberg, Germany
Detailed description
A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- 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 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 6 Jun 2022.
- Derived from this study: PubMed 39495243Amoey D, Samy M, Elbasha K, Alali A, Landt M, Kurniadi A, Nef H, Tolg R, Richardt G, Mankerious N. Predictors and Outcomes of Inappropriate Dosing of Direct Oral Anticoagulants in Patients Receiving Transcatheter Aortic Valve Implantation. Cardiol Ther. 2024 Dec;13(4):761-773. doi: 10.1007/s40119-024-00387-0. Epub 2024 Nov 4.
- Derived from this study: PubMed 39378384Samy M, Landt M, Mankerious N, Kurniadi A, Alotaibi S, Toelg R, Abdel-Wahab M, Nef H, Allali A, Richardt G, Elbasha K. ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation. Catheter Cardiovasc Interv. 2024 Nov;104(6):1251-1259. doi: 10.1002/ccd.31259. Epub 2024 Oct 8.
- Derived from this study: PubMed 36017287Alotaibi S, Elbasha K, Landt M, Kaur J, Kurniadi A, Abdel-Wahab M, Toelg R, Richardt G, Allali A. Prognostic Value of HFA-PEFF Score in Patients Undergoing Transcatheter Aortic Valve Implantation. Cureus. 2022 Jul 22;14(7):e27152. doi: 10.7759/cureus.27152. eCollection 2022 Jul.
- Derived from this study: PubMed 31959428Abdelghani M, Mankerious N, Landt M, Toelg R, Abdel-Wahab M, Richardt G. Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium. Am J Cardiol. 2020 Mar 15;125(6):931-940. doi: 10.1016/j.amjcard.2019.12.022. Epub 2019 Dec 27.
- 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.
Mohamed Abdel-Wahab, MD contact
Ralph Toelg contact
Gert Richardt, MD study chair
Heart Center, Segeberger Kliniken
Mohamed Abdel-Wahab, MD principal investigator
Heart Center, Segeberger Kliniken
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 Segeberger Kliniken 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 6 Jun 2022. 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 (msabdelwahab@gmail.com), 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 NCT03192774, which also lists 4 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 6 Jun 2022.