The Prospective Segeberg TAVI Registry

NCT03192774 | Recruiting FDA Device

• 1 other identifier: SK 109 -- 168/11
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Cardiovascular and not cardiovascular death

  Up to 10 years

Secondary Outcomes (1)

• Structural valve deterioration

  Up to 10 years

Interventions

Transcatheter Aortic Valve Implantation DEVICE

Interventional replacement of the aortic valve

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers patient population treated with TAVI.

You may qualify if:

• All patients treated with TAVI

You may not qualify if:

• None

Sponsors & Collaborators

• Segeberger Kliniken GmbH: lead

Study Sites (1)

Heart Center, Segeberger Kliniken

Bad Segeberg, 23795, Germany

RECRUITING

Related Publications (4)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Gert Richardt, MD

  Heart Center, Segeberger Kliniken

  STUDY CHAIR

• Mohamed Abdel-Wahab, MD

  Heart Center, Segeberger Kliniken

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abdel-Wahab, MD

CONTACT

msabdelwahab@gmail.com

Ralph Toelg

CONTACT

ralph.toelg@segebergerkliniken.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 20, 2017
• Study Start: September 1, 2007
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)