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Evaluation of morphological and functional outcome of early leaflet thrombosis after TAVI

Evaluation of morphological and functional outcome of early leaflet thrombosis after TAVI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023520
Enrollment
20
Registered
2020-11-18
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leaflet thrombosis after TAVI

Interventions

Group 1: Within this unicenter prospective observational study, all patients with early diagnosed asymptomatic leaflet thrombosis on the TAVI prosthesis will be reexamined. 2 years after implantation

Sponsors

Universitätsherzzentrum Freiburg-Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
59 Years to 100 Years

Inclusion criteria

Inclusion criteria: • Intervention at least 2 years ago • Existing post-interventional CT diagnostics during the implantation stay • Consent to participate in the study with CT implementation •> 59. age

Exclusion criteria

Exclusion criteria: Lack of consent • Oral anticoagulation

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the quantitative measurement of possible calcification of the prosthetic cusps using CT.

Secondary

MeasureTime frame
-Density measurement of the prosthetic cusps derived from the CT. - Thickening or hypomobility of the cusps of the prosthesis. - Limitation of mobility of the prosthesis cups. - Deterioration of functional valve parameters in echocardiography (maximum speed, mean / maximum pressure gradient, speed quotient, aortic valve prosthesis opening area index, transvalvular and paravalvular insufficiency) - Clinical parameters such as stroke / TIA rate, systemic embolism, myocardial infarction, hospitalization for heart failure, syncope, NYHA status changes

Countries

Germany

Contacts

Public ContactPhilipp Ruile

Klinik für Kardiologie und Angiologie IIUniversitätsherzzentrum Freiburg - Bad Krozingen

philipp.ruile@universitaet-herzzentrum.de076334020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026