Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion

Atrial Fibrillation Clinical Trial

— FADE-DRT  

Official title:

Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502017
• Other study ID #: TCAI_LAAO
• Status: Recruiting
• Phase: Phase 4
• Start date: August 5, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2020
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Domenico G Della Rocca, MD
• Phone: 7375296806
• Email: domenicodellarocca[@]hotmail.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Device-Related Thrombosis
• Left Atrial Appendage Occlusion
• Thrombosis

Intervention

Drug:
• ASA plus Clopidogrel
OAC (6 weeks) + DAPT (until 6 months) + ASA
• Genetic-Tailored AntiThrombotic Strategy
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
• Half-Dose of novel OAC
Half Dose of novel OAC post-device Implantation

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Stroke, Systemic Embolism, and Device-related Thrombosis		1 year
Primary	Incidence of Major Bleeding Events		1 year
Secondary	Incidence of Minor Bleeding Events		1 year