Evaluate whether a rivaroxaban-based strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing subclinical valve leaflet thickening and motion abnormalities - as evaluated by 4DCT imaging at three…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rate of patients with at least one prosthetic leaflet with > 50% motion
reduction as assessed by cardiac 4DCT-scan (total N = 300).
Secondary outcome
- 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.
Background summary
An optimal therapy for TAVR patients is not known and only based on consensus,
there is an unmet need to identify the best medical treatment in patients
undergoing TAVR.
Study objective
Evaluate whether a rivaroxaban-based strategy, following successful TAVR,
compared to an antiplatelet-based strategy, is superior in reducing subclinical
valve leaflet thickening and motion abnormalities - as evaluated by 4DCT
imaging at three months following TAVR.
Study design
Within the GALILEO main study, patients will be randomized 1:1 to an
antiplatelet-based strategy vs. rivaroxaban-based strategy. At selected sites
participating subjects will be offered to additionally take part in the
GALILEO-4D sub study. For the GALILEO-4D sub study the following additional
assessments will be performed at 90 days (+/- 15) after randomization in the
main study: 4DCT scan, tECG and functional NYHA classification.
Intervention
during visit main Galileo studie: 4DCT, tECG and NYHA functional class
Study burden and risks
Subjects will have an additional radiation burden of 5-15 mSv for the
GALILEO-4D sub study. This corresponds to 2-6 times the background radiation in
the Netherlands (ca. 2.5 mSv annually).
Westblaak 92
Rotterdam 3012 KM
NL
Westblaak 92
Rotterdam 3012 KM
NL
Listed location countries
Age
Inclusion criteria
1. Patient included in the randomized GALILEO trial
2. Written informed consent
Exclusion criteria
1. Severe renal insufficiency (eGFR < 30 ml/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction >= stage 2
2. Iodinate contrast media allergy or other conditions that prohibit CT imaging (i.e. multiple myeloma, etc.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02833948 |
| CCMO | NL59279.018.17 |