Status:
COMPLETED
Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
Lead Sponsor:
Fundación EPIC
Conditions:
Atrial Fibrillation
Heart Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an importa...
Detailed Description
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an importa...
Eligibility Criteria
Inclusion
- Age\> 18 years.
- Stage V chronic kidney disease (GFR \<15 ml / min) in hemodialysis at the time of left atrial appendage closure.
- History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
- Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
- High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC\> 2).
- The patient has been informed of the characteristics of the study and has provided written informed consent.
Exclusion
- Life expectancy \< 2 years.
- Indication for OA different from NVAF.
- Severe pericardial effusion.
- Previous percutaneous closure of atrial septal defect.
- Intracardiac thrombus.
- Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) \> 1.5.
- The patient refuses to participate in the study.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03446794
Start Date
March 14 2018
End Date
January 7 2022
Last Update
June 24 2022
Active Locations (20)
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1
Hospital de Vinalopó
Torrevieja, Alicante, Spain, 03293
2
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
3
Hospital Costa del Sol
Marbella, Málaga, Spain, 29603
4
Hospital General Universitario de Alicante
Alicante, Spain, 03010