← Back to Search

LAAC Device

WATCHMAN FLX Device for Atrial Fibrillation (CHAMPION-AF Trial)

N/A

Waitlist Available

Led By Shephal Doshi, 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 documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)

The subject has a calculated CHA2DS2-VASc score of 2 or greater for men and 3 or greater for women

Must not have

The subject has a cardiac tumor

The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60-months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the WATCHMAN FLX device is a good alternative to blood-thinners for people with non-valvular atrial fibrillation.

Who is the study for?

This trial is for adults with non-valvular atrial fibrillation who can attend follow-up visits and are suitable for certain drug regimens. They must have a CHA2DS2-VASc score of at least 2 (men) or 3 (women). Exclusions include those needing long-term anticoagulation for other reasons, recent stroke/TIA, active infections, known procedure contraindications, allergies to oral anticoagulants/aspirin, planned surgeries around the implant time, and women who are or may become pregnant.

What is being tested?

The CHAMPION-AF Clinical Trial is testing if the WATCHMAN FLX device to close the left atrial appendage is as effective as non-vitamin K oral anticoagulants in preventing strokes in patients with atrial fibrillation without heart valve issues.

What are the potential side effects?

Potential side effects from the WATCHMAN FLX device could include complications from the implant procedure like bleeding or heart tissue damage. Non-vitamin K oral anticoagulants might cause bleeding problems, allergic reactions, and possibly liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a type of irregular heartbeat not caused by a heart valve issue.

Select...

My CHA2DS2-VASc score is 2 or more (if I am a man) or 3 or more (if I am a woman).

Select...

I can understand and am willing to sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a tumor in my heart.

Select...

I need long-term blood thinners for reasons not related to preventing stroke from atrial fibrillation.

Select...

I am allergic or cannot take blood thinners or aspirin.

Select...

I currently have an infection.

Select...

I have severe heart failure.

Select...

I am experiencing symptoms of pericarditis.

Select...

I have had surgery or a device placed for a hole in my heart.

Select...

I cannot undergo procedures involving tubes inserted into my body due to health risks.

Select...

I do not have a left atrial appendage, or it has been surgically closed.

Select...

I had a heart attack within the last 30 days.

Select...

I am prescribed long-term medication to prevent blood clots.

Select...

I am currently experiencing active bleeding.

Select...

I had a major bleeding event in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60-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

WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism

WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism

WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)

Secondary study objectives

The occurrence of ISTH major bleeding

The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)