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NOTION-4: Prospective study on the impact of different anti-thrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter bioprosthetic aortic valves.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518547-38-00
Enrollment
350
Registered
2024-11-11
Start date
2021-05-12
Completion date
Unknown
Last updated
2025-02-04

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

Conditions

Patients who have undergone successful transcatheter bioprosthetic aortic valve implantation (TAVI)

Brief summary

The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.

Detailed description

The combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding at 1 year, 3 years and 5 years after randomization, The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at 3 months, 1, 3 and 5 years after TAVI, Number of prosthetic leaflets with HALT at CT-scan at 3 months, 1 year, 3 and 5 years., The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT., Any type of stroke – including ischemic and hemorrhagic stroke, All-cause mortality, Cardiovascular mortality as defined in current VARC definition, Major bleeding or life-threatening bleeding, Need for re-intervention (valve-in-valve TAVI, paravalvular leak closure, SAVR), Aortic bioprosthetic dysfunction (according to EAPCI/ESC/EACTS definitions), Rate of bioprosthetic valve failure (according to EAPCI/ESC/EACTS definitions), NYHA classification, Quality of life scores

Interventions

DRUGDABIGATRAN ETEXILATE
DRUGAPIXABAN
DRUGCLOPIDOGREL
DRUGACETYLSALICYLIC ACID
DRUGRIVAROXABAN
DRUGEDOXABAN

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.

Secondary

MeasureTime frame
The combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding at 1 year, 3 years and 5 years after randomization, The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at 3 months, 1, 3 and 5 years after TAVI, Number of prosthetic leaflets with HALT at CT-scan at 3 months, 1 year, 3 and 5 years., The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT., Any type of stroke – including ischemic and hemorrhagic stroke, All-cause mortality, Cardiovascular mortality as defined in current VARC definition, Major bleeding or life-threatening bleeding, Need for re-intervention (valve-in-valve TAVI, paravalvular leak closure, SAVR), Aortic bioprosthetic dysfunction (according to EAPCI/ESC/EACTS definitions), Rate of bioprosthetic valve failure (according to EAPCI/ESC/EACTS definitions), NYHA classification, Quality o

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026