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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
OPTION Trial 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.Check my eligibility
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.See study design
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.
OPTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My risk score for stroke is high based on my health factors.
OPTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-procedural bleeding
Stroke, all cause death, and systemic embolism
Secondary outcome measures
Major bleeding
OPTION 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.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
718 Previous Clinical Trials
931,348 Total Patients Enrolled
68 Trials studying Atrial Fibrillation
26,688 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke or a mini-stroke in the last 2 months.I cannot undergo procedures involving tubes inserted into my body due to certain health reasons.There are signs that the heart is compressed due to fluid buildup.I am legally old enough to participate in this study according to my local laws.I had or am planning to have a procedure for AF using catheters within specific time frames.I have been diagnosed with the most severe heart failure.I have had surgery to close the left atrial appendage in my heart.I haven't had major bleeding or unresolved issues from bleeding in the last 2 weeks.You have a mechanical heart valve.I am experiencing symptoms of pericarditis.I understand the study and agree to participate.Your doctor believes you have less than two years to live.My risk score for stroke is high based on my health factors.I have a tumor in my heart.You are able to have a transesophageal echocardiogram (TEE) test.I had or will have heart surgery or a major procedure within 30 days before or 60 days after joining the study.I cannot take blood thinners or aspirin due to bleeding risk or allergies.I currently have an active infection.I can and will come back for all needed follow-ups.I need long-term blood thinners for a condition other than preventing stroke due to atrial fibrillation.I had a heart attack within the last 3 months.You have had surgery to repair a hole in your heart, or you have a device to close a hole in your heart.
Research Study Groups:
This trial has the following groups:- Group 1: WATCHMAN FLX
- Group 2: Market-approved OAC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT03795298 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being enrolled in this experiment?
"As per clinicaltrials.gov, this particular trial is no longer actively recruiting patients; the post was first published on May 20th 2019 and last updated on November 29th 2022. Conversely, 477 other trials are presently enrolling participants."
Answered by AI
Are there any American medical centers conducting this research?
"This medical trial is being conducted over 100 sites, including Methodist Hospital of Indianapolis in Indiana, Rex Hospital in North carolina and St. John's Hospital in Illinois amongst other locations."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am only on Pradaxa and furosemide. I was on flecanide but was Taken off when a test revealed a little bit of plaque in my arteries.I have heard good things about the Watchman device on patient advocacy website.
PatientReceived 1 prior treatment
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