NCT05660811

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure - Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study - PILOT

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SAFE-LAAC CKD Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis

Detailed description

Background: Transcatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. However, an optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue and may significantly contribute to long-term safety and efficacy. Nowadays LAAC is mainly performed in patients with contraindications for oral anticoagulation due to high bleeding risk. Dialyzed patients with end-stage renal disease and atrial fibrillation have simultaneously high thromboembolic and bleeding risk. Such patients were excluded from randomized trials and data on the LAAC efficacy in this population is limited thus prospective studies are warranted. Objective: SAFE-LAAC CKD Trial has been designed as a comparative health effectiveness study with the following aims: 1. compare the safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer or WATCHMAN device (randomized comparison) 2. compare the safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with a single antiplatelet agent (nonrandomized comparison) Patient population: Patients (n=80) with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis, after successful LAAC with Amplatzer or WATCHMAN device Perspective: Results of this pilot trial will provide: 1. data to aid practitioners and guideline writers recommend the most optimal antithrombotic treatment after LAAC, 2. data on the safety and efficacy of LAAC in dialyzed patients, and 3. data to support power calculations for designing future randomized trials. Methodology: SAFE LAAC CKD has been designed as a multicenter (planned contribution of 7 centers in Poland), open-label, comparative health effectiveness trial with central, independent adjudication of events comprising the primary end-point. The first part of the trial is randomized and after 6 months of follow-up continues for another 12 months as a non-randomized study. Timeline: The duration of the trial has been planned for 5 years. The enrollment phase has been planned for 3 years.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	short postimplantation dual antiplatelet therapy	continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet
DRUG	extended postimplantation dual antiplatelet therapy	stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months
DRUG	long-term treatment with a single antiplatelet agent	continuing long-term treatment with single antiplatelet agent
DRUG	6 months treatment with a single antiplatelet agent	continuing single antiplatelet agent up until 6 months

Timeline

• Start date: 2022-09-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-12-21
• Last updated: 2024-06-25

Locations

1 site across 1 country: Poland