NCT07724301

Brief Summary

The goal of this observational study is to learn about the effects of antiplatelet drugs on patients over the age of 80 with atrial fibrillation. The main question it aims to answer is:

  • Is platelet reactivity effectively controlled in patients over the age of 80 diagnosed with atrial fibrillation following the Watchman procedure.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
24mo left

Started Aug 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 20, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

atrial fibrillationthrombosisbleedingelderly over 80antiplatelet drugsaspirinclopidogrelplatelet function

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity

    platelet reactivity will be measured before and after antiplatelet treatment in patients over 80. Outcomes will include 1) platelet aggregation, 2) integrin activation, 3) alpha and dense granule secretion, 4) T-TAS activation, and 5) TEG.

    blood draw will occur prior to Watchman procedure and antiplatelet administration and 90 days following Watchman procedure while patients are taking antiplatelet drugs

Study Arms (1)

Patients with atrial fibrillation over the age of 80

Patients over the age of 80 diagnosed with atrial fibrillation receiving ether aspirin alone or aspirin and clopidogrel

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients over the age of 80 who have been diagnosed with atrial fibrillation and will receive the Watchman Procedure and receive antiplatelet drugs following procedure.

You may qualify if:

  • diagnosed with atrial fibrillation, scheduled for a Watchman Procedure

You may not qualify if:

  • Healthy, taking antiplatelet medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationThrombosisHemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Central Study Contacts

Michael Holinstat, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

IPD information will be made available on a request basis and determination will be made with HIPAA policies being taken into consideration and the treating physician.