Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Cardiovascular Diseases Clinical Trial

— WATCH-HD  

Official title:

Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446794
• Other study ID #: WATCH-HD EPIC-06
• Status: Completed
• Start date: March 14, 2018
• Est. completion date: January 7, 2022

Study information

• Verified date: June 2022
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.

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 important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Bleeding
• Cardiovascular Diseases
• Heart Diseases
• Kidney Diseases
• Renal Disease
• Renal Insufficiency, Chronic

Intervention

Other:
• Non Intervention
To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Santa Creu y Sant Pau	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Juan Ramón Jiménez Huelva	Huelva
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario de Gran Canaria Dr. Negrín	Las Palmas de Gran Canaria
Spain	Hospital Universitario de León	León
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Universitario Virgen de Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital de Vinalopó	Torrevieja	Alicante
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality, stroke and bleeding	Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC = 2).; Systemic embolism, Major bleeding event (BARC = 2)	24 month
Secondary	Periprocedural major adverse events	Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)	2 days
Secondary	Echocardiographic adverse events during follow up	Prevalence of device thrombus	24 month
Secondary	Echocardiographic adverse events during follow up	Prevalence and severity of residual leak	24 month

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