A comparison between rivaroxaban-based strategy and antiplatelet-based strategy following successful TAVR for prevention of leaflet thickening and reduced leaflet motion as evaluated by four-dimensional, volume-rendered computed tomography (4DCT) in a population of patients coming from the GALILEO randomized trial

A comparison between rivaroxaban-based strategy and antiplatelet-based strategy following successful TAVR for prevention of leaflet thickening and reduced leaflet motion as evaluated by four-dimensional, volume-rendered computed tomography (4DCT) in a population of patients coming from the GALILEO randomized trial - GALILEO-4D

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45677

Enrollment

Registered

2017-06-06

Start date

2017-10-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

new valve leaflet valve leaflet thickening/movement

Interventions

during visit main Galileo studie: 4DCT, tECG and NYHA functional class

antiplatelet-based

rivaroxaban-based

TAVR

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patient included in the randomized GALILEO trial 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe renal insufficiency (eGFR = stage 2 2. Iodinate contrast media allergy or other conditions that prohibit CT imaging (i.e. multiple myeloma, etc.)

Design outcomes

Primary

Measure	Time frame
The rate of patients with at least one prosthetic leaflet with > 50% motion reduction as assessed by cardiac 4DCT-scan (total N = 300).	—

Secondary

Measure	Time frame
- The rate of prosthetic leaflets with > 50% motion reduction as assessed by cardiac 4DCT-scan (based on a total of 900 observations in N = 300 patients). - The rate of patients with at least one prosthetic leaflet with thickening as assessed by cardiac 4DCT-scan (total N = 300). - The rate of prosthetic leaflets with thickening as assessed by cardiac 4DCT-scan (based on a total of 900 observations in N = 300 patients). - Aortic transvalvular mean pressure gradient and effective orifice area (cm2) as determined by transthoracic echocardiography. - Functional NYHA class. - Death, first thromboembolic event (DTE), and safety endpoints (see GALILEO trial) will be assessed in the main GALILEO study and analyzed in the GALILEO-4D substudy with regards to occurence of the leaflet abnormalities - as exploratory analysis.	—

Measure

Time frame

- The rate of prosthetic leaflets with > 50% motion reduction as assessed by cardiac 4DCT-scan (based on a total of 900 observations in N = 300 patients). - The rate of patients with at least one prosthetic leaflet with thickening as assessed by cardiac 4DCT-scan (total N = 300). - The rate of prosthetic leaflets with thickening as assessed by cardiac 4DCT-scan (based on a total of 900 observations in N = 300 patients). - Aortic transvalvular mean pressure gradient and effective orifice area (cm2) as determined by transthoracic echocardiography. - Functional NYHA class. - Death, first thromboembolic event (DTE), and safety endpoints (see GALILEO trial) will be assessed in the main GALILEO study and analyzed in the GALILEO-4D substudy with regards to occurence of the leaflet abnormalities - as exploratory analysis.

—

Countries

Denmark, Germany, Netherlands, Switzerland, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)