Menu
Recruiting NCT03192774

The Prospective Segeberg TAVI Registry

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Aortic Valve Implantation.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg

Overview

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.

Interventions

  • Device Transcatheter Aortic Valve Implantation
    Interventional replacement of the aortic valve

Primary outcome measures

  • Mortality [Time frame: Up to 10 years]
Secondary outcome measures (1)
  • Structural valve deterioration [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

  • All patients treated with TAVI

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Heart Center, Segeberger Kliniken — Bad Segeberg

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. PMID 39495243
  • Samy 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. PMID 39378384
  • Alotaibi 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. PMID 36017287
  • Abdelghani 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. PMID 31959428

Identifiers

NCT: NCT03192774 · SK 109 -- 168/11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗