Recruiting

Genetic Variants

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04115436

Conditions

Thromboembolic Events

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Thromboembolic Events

Study ID

NCT04115436

Start date

Oct 1, 2019

Status verified date

Oct, 2019

Completion date

Oct 1, 2020

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Proportion of difference in the SNP profile between the Stroke (+) and no-stroke patients [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Sanghamitra Mohanty, MD

5125448198mitra1989@gmail.com

Angel Mayedo, MD

angel.mayedo@stdavids.com

Locations

Texas Cardiac Arrhythmia Institute

Recruiting

Austin, Texas, United States, 78705

Contacts

Sanghamitra Mohanty, MD

mitra1989@gmail.com

Angel Mayedo, MD

angel.mayedo@stdavids.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Oct 17, 2019

Last verified

Oct, 2019

Keywords

  • LAA isolation, stroke, anticoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2019-10-17.