The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)

Phase 1

• Conditions: Patients who have undergone successful transcatheter bioprosthetic aortic valve implantation (TAVI); MedDRA version: 20.0Level: LLTClassification code 10077017Term: TAVISystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003361-19-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
Residing in Denmark
Provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292

Exclusion Criteria

Atrial fibrillation or any other indication for lifelong OAC therapy
Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g., intracranial haemorrhage or major gastrointestinal bleeding
Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)
Patient with absolute indication for anti-thrombotic therapy, e.g., recent PCI
Iodine contrast allergy or other condition that prohibits CT imaging
Age <18 years
Women of childbearing potential, pregnant or nursing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of NOTION-4 is to investigate the incidence and temporal dynamics of subclinical leaflet thickening (HALT) by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. ;Secondary Objective: Additionally, this study aims to examine a possible association between HALT and thromboembolic events.;Primary end point(s): The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.;Timepoint(s) of evaluation of this end point: One year after TAVI.