Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients completed successful elective TAVI for severe aortic valve stenosis
with any commercially-available transcatheter heart valve (THV).
-Correct positioning of a single prosthetic heart valve into the proper
anatomical location
-Device success, defined by Mean aortic valve gradient < 20 mmHg; Peak
transvalvular velocity <3.0 m/s; Aortic valve regurgitation of 2 or less, No
periprocedural complications
- No overt stroke
- No uncontrolled bleeding
- No major vascular complication defined by the VARC-3 consensus, No formal
indication for oral anticoagulation
- No cardiac structural complication defined by the VARC-3 consensus
- Prevention of thromboembolic complications in patients with atrial
fibrillation
- Prevention for recurrent venous thromboembolism
- Prevention for recurrent pulmonary embolism

Exclusion Criteria

History of life-threatening or major bleeding event >= BARC 3b definitions
within the last year
Other conditions with a high risk of bleeding
- Active peptic ulcer or upper gastrointestinal bleeding within last 3 months
prior to enrolment
- Malignancy with high risk of bleeding
- Recent unresolved brain of spinal injury
- Spinal or ophthalmic surgery within last 3 months prior to enrolment
- Intracranial haemorrhage
- Esophagal varices
- Atriovenous malformations with high risk of bleeding
- Vascular aneurysms
- Major intraspinal or intracerebral vascular abnormalities
Hypersensitivity or contraindications to edoxaban
Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to
enrolment
Concomitant percutaneous coronary intervention (PCI) during the TAVI procedure,
requiring DAPT after the procedure.
Renal impairment defined as by dialysis-dependency or GFR < 30 mL/min at
time of enrollment
Active bleeding or bleeding diasthesis including thrombocytopenia (platelet
count < 50.000 cells/UL), thrombobasthenia, haemophilia or von Willebrand
disease
Patients unable to adhere to or complete the investigational protocol for any
reason including but not limited to geographical residence, psychiatric
condtition or life-threatening disease
Pregnant or breast-feeding subjects
Current participation in clinical trials that potentially interfere with the
current study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate whether edoxaban affects the incidence of aortic valve leaflet<br /><br>thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months<br /><br>treatment.</p><br>

Secondary Outcome Measures