NCT04115436

Brief Summary

Life-long therapy with oral anticoagulants (OAC) is strongly recommended in AF patients receiving left atrial appendage isolation (LAAI) to prevent thromboembolic (TE) events. However, some patients are observed to remain stroke-free while off OACs for years whereas others experience TE events if OAC is discontinued even for a short period of time. Therefore, we aim to evaluate the association of genetic variants (single nucleotide polymorphisms - SNPs) with off-anticoagulation stroke-risk in AF patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 2, 2019

Last Update Submit

October 14, 2019

Conditions

Thromboembolic Events

Keywords

LAA isolation, stroke, anticoagulation

Outcome Measures

Primary Outcomes (1)

  • Proportion of difference in the SNP profile between the Stroke (+) and no-stroke patients

    Proportion of difference in the SNP profile between the Stroke (+) and no-stroke patients

    1 day

Study Arms (2)

stroke (+)

Patients experiencing thromboembolic events following a brief discontinuation of anticoagulant or having thrombus on the LAA occlusion device

No-stroke

Patients remaining stroke-free months after discontinuation of anticoagulants

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AF patients following LAA isolation

You may qualify if:

  • \- i. male or female over 18 years of age at the time of enrollment ii. have received LAAI procedure iii. Discontinued OAC for any duration

You may not qualify if:

  • i. end-stage renal or liver disease ii. on oral anticoagulation for any other condition iii. pregnant, breastfeeding, or unwilling to provide consent iv. presence of other conditions or abnormalities that in the opinion of the Investigator would compromise the quality of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

ThromboembolismStroke

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Sanghamitra Mohanty, MD

CONTACT

5125448198mitra1989@gmail.com

Angel Mayedo, MD

CONTACT

angel.mayedo@stdavids.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 17, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)