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Anticoagulant

Left Atrial Appendage Closure vs Anticoagulation for Atrial Fibrillation (OPTION Trial)

N/A
Waitlist Available
Led By Oussama Wazni, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
Be older than 18 years old
Must not have
Contraindications (anatomical or medical) to percutaneous catheterization procedures.
The subject has documented NYHA Class IV heart failure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the WATCHMAN FLX Device is a better alternative to blood thinners for high-risk patients with non-valvular atrial fibrillation who have had a catheter ablation.

Who is the study for?
This trial is for high-risk patients with non-valvular atrial fibrillation who've had or will have catheter ablation. Participants must have a CHA2DS2-VASc score of at least 2 (males) or 3 (females), be able to undergo TEE exams, and consent to follow-up visits. Exclusions include recent MI, other medical conditions requiring chronic anticoagulation, mechanical heart valves, pregnancy potential without contraception, severe heart failure, active infections, and major bleeding events recently.
What is being tested?
The study aims to compare the effectiveness of the WATCHMAN FLX Device for left atrial appendage closure against standard oral anticoagulants in preventing stroke after catheter ablation in atrial fibrillation patients. It's testing if the device can be an alternative for those who are at risk of stroke but may face issues with long-term blood thinners.
What are the potential side effects?
Potential side effects could include complications from implanting the device like bleeding or infection; reactions related to anesthesia during procedures; possible discomfort from TEE exams; and risks associated with stopping oral anticoagulants if that's part of their current treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My risk score for stroke is high based on my health factors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo procedures involving tubes inserted into my body due to certain health reasons.
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I have been diagnosed with the most severe heart failure.
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I have had surgery to close the left atrial appendage in my heart.
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I haven't had major bleeding or unresolved issues from bleeding in the last 2 weeks.
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I am experiencing symptoms of pericarditis.
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I have a tumor in my heart.
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I had or will have heart surgery or a major procedure within 30 days before or 60 days after joining the study.
Select...
I currently have an active infection.
Select...
I had a heart attack within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Non-procedural bleeding
Stroke, all cause death, and systemic embolism
Secondary study objectives
Major bleeding

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WATCHMAN FLXExperimental Treatment1 Intervention
WATCHMAN FLX implant including modified post-implant drug regimen.
Group II: Market-approved OACActive Control1 Intervention
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WATCHMAN FLX Implant
2019
N/A
~1600

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
744 Previous Clinical Trials
856,223 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
32,490 Patients Enrolled for Atrial Fibrillation
Oussama Wazni, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
513 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
513 Patients Enrolled for Atrial Fibrillation

Media Library

Market-approved OAC (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03795298 — N/A
Atrial Fibrillation Research Study Groups: WATCHMAN FLX, Market-approved OAC
Atrial Fibrillation Clinical Trial 2023: Market-approved OAC Highlights & Side Effects. Trial Name: NCT03795298 — N/A
Market-approved OAC (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03795298 — N/A
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT03795298 — N/A
~249 spots leftby Nov 2025
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