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Randomized Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT) - Substudy of the GALILEO-trial (GALILEO-4D)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms. The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy. The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.
Details
| Lead sponsor | ECRI bv |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 231 |
| Start date | 2016-05 |
| Completion | 2019-03-06 |
Conditions
- Aortic Valve Stenosis
- Cardiovascular Diseases
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Thrombosis
Interventions
- Acetylsalicylic acid
- Clopidogrel
- Rivaroxaban
Primary outcomes
- Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan — 3 months
Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (\<50%), (III) moderate to severely reduced (\>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is \> 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets.
Countries
United States, Canada, Denmark, Germany, Netherlands, Sweden, Switzerland