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

NCT04502017 | Unknown Phase 4 DMC

• 1 other identifier: TCAI_LAAO
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

left atrial appendage; Watchman; antithrombotic therapy; device-related thrombosis

Outcome Measures

Primary Outcomes (2)

• Composite of Stroke, Systemic Embolism, and Device-related Thrombosis

  1 year

• Incidence of Major Bleeding Events

  1 year

Secondary Outcomes (1)

• Incidence of Minor Bleeding Events

  1 year

Study Arms (3)

Standard Antithrombotic Therapy

ACTIVE COMPARATOR

OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone

Drug: ASA plus Clopidogrel

Genetic-Tailored AntiThrombotic Strategy

ACTIVE COMPARATOR

OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone

Drug: Genetic-Tailored AntiThrombotic Strategy

Half-Dose NOAC

ACTIVE COMPARATOR

Half Dose of Novel OAC

Drug: Half-Dose of novel OAC

Interventions

ASA plus Clopidogrel DRUG

OAC (6 weeks) + DAPT (until 6 months) + ASA

Standard Antithrombotic Therapy

Genetic-Tailored AntiThrombotic Strategy DRUG

Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype

Genetic-Tailored AntiThrombotic Strategy

Half-Dose of novel OAC DRUG

Half Dose of novel OAC post-device Implantation

Half-Dose NOAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Domenico G Della Rocca, MD

CONTACT

7375296806; domenicodellarocca@hotmail.it

Andrea Natale, MD

CONTACT

5127842651; andrea.natale@stdavids.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: August 5, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)