Atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego- Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization 2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis 3. Age >= 18 yrs 4. Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits 5. The participant is willing to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion. 2. Indications to chronic anticoagulation 3. Known allergy to clopidogrel of acetylsalicylic acid 4. Diagnosis of coagulation disorders 5. Peridevice leaks greater than 5mm 6. Thrombus in the left atrium on the qualifying imaging of the left atrium 7. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 8. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrolment 9. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT in patients with end-stage renal disease on chronic dialysis (randomized comparison) 2. To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison).;Secondary Objective: Assessment of safety and efficacy of transcatheter left atrial appendage occlusion in patients with end-stage renal disease on chronic dialysis (retrospective registry);Primary end point(s): Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC). ;Timepoint(s) of evaluation of this end point: English 5 months 17 months landmark analysis at 17months of endpoints gathered between the 5 and 17months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): individual components of the composite primary end point and: 1. any bleeding 2. new intermediate and large ischemic lesions (=4mm in size) in central nervous system as assessed by brain MRI 3. new cognitive disorders as assessed by Addenbrooke's Cognitive Examination (ACE-III) 4. thrombosis of the dialysis access 5. efficacy and safety of LAAC in the periprocedural and 1 month follow-up ;Timepoint(s) of evaluation of this end point: 5 months 17 months landmark analysis at 17months of endpoints gathered between the 5 and 17months | — |
Countries
Poland
Contacts
Public ContactClinical Research Support Center
National Institute of Cardiology
Outcome results
None listed