Atrial Fibrillation, Device-Related Thrombosis, Left Atrial Appendage Occlusion
Conditions
Keywords
left atrial appendage, Watchman, antithrombotic therapy, device-related thrombosis
Brief summary
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Detailed description
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
Interventions
OAC (6 weeks) + DAPT (until 6 months) + ASA
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
DRUGHalf-Dose of novel OAC
Half Dose of novel OAC post-device Implantation
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women ≥18 years of age * Successful LAAC procedure (device implanted without procedural or bleeding complication). * Patients contraindicated or unsuitable for long-term OAC. * History of AF (permanent or persistent or paroxysmal). * Written informed consent by the patient or designee if the patient is unable to consent
Exclusion criteria
* Life expectancy \< 2 years. * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of Stroke, Systemic Embolism, and Device-related Thrombosis | 1 year |
| Incidence of Major Bleeding Events | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Minor Bleeding Events | 1 year |
Countries
United States
Contacts
Primary ContactDomenico G Della Rocca, MD
Backup ContactAndrea Natale, MD
Outcome results
None listed