ENRICH-TAVI

Phase 4

Recruiting

• Conditions: Severe aortic stenosis; D001024

• Registration Number: JPRN-jRCTs071180025
• Lead Sponsor: Kenichi Tsujita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 20 years and older
2. Patients with severe aortic stenosis who are scheduled to undergo TAVI
3. Patients who need anticoagulation therapy due to atrial fibrillation
4. Patients with the informed consent

Exclusion Criteria

1. Patients with the contraindications of Edoxaban
(A) Patients with a history of hypersensitivity to the components of edoxaban
(B) Patients with serious bleeding symptoms
(C) Severe liver disease with blood coagulation abnormalities and clinically important bleeding risk
(D) Acute bacterial endocarditis
(E) Severe renal dysfunction (creatinine clearance less than 15 mL / min)
2. Valvular atrial fibrillation (rheumatic mitral valve stenosis or artificial valve replacement)
3.Patients who judged unsuitable for participating in the study on the following items;
(A) High bleeding risk
1). Congenital or acquired hemorrhagic disease
2). Active ulcerative digestive tract disease
3). Thrombocytopenia
4). platelet related diseases
5). History of hemorrhagic stroke within 3 months
6). Severe hypertension with poor control
7). Patients with recent surgical history (etc. brain, spinal cord, ophthalmic)
(B) Severe liver disease
(C) Pregnant women
(D) Lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in maximal leaflet thickness between three months and 1 week after TAVI