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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-months
Awards & highlights
CHAMPION-AF Trial 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.Check my eligibility
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.See study design
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.
CHAMPION-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CHAMPION-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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)
CHAMPION-AF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Device GroupExperimental Treatment1 Intervention
Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device
Group II: Control GroupActive Control1 Intervention
Randomized to non-vitamin K oral anticoagulant (NOAC)
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
930,398 Total Patients Enrolled
10 Trials studying Stroke
7,033 Patients Enrolled for Stroke
Shephal Doshi, MDPrincipal InvestigatorPacific Heart Institute and Providence St. John's Health Center
2 Previous Clinical Trials
675 Total Patients Enrolled
Marty Leon, MDStudy ChairNew York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
2 Previous Clinical Trials
608 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor in my heart.I need long-term blood thinners for reasons not related to preventing stroke from atrial fibrillation.I am considered fit for the treatment plans in this study.I currently have an infection.I am not pregnant nor planning to become pregnant during the study.I have severe heart failure.There are signs of a condition called tamponade physiology.My atrial fibrillation (AF) can be reversed or is temporary.I am experiencing symptoms of pericarditis.I cannot undergo procedures involving tubes inserted into my body due to health risks.I am allergic or cannot take blood thinners or aspirin.I have had surgery or a device placed for a hole in my heart.I do not have a left atrial appendage, or it has been surgically closed.I can and will come back for all needed follow-ups and tests.I am legally old enough to participate in this study according to my local laws.You have a mechanical heart valve.I had a heart attack within the last 30 days.You have been told by a doctor that you are expected to live for less than 3 years.I have a type of irregular heartbeat not caused by a heart valve issue.My CHA2DS2-VASc score is 2 or more (if I am a man) or 3 or more (if I am a woman).You have a certain score based on your medical history and age that may affect your heart health.I can understand and am willing to sign the consent form.I had a stroke or a mini-stroke in the last 30 days.I am prescribed long-term medication to prevent blood clots.I am currently experiencing active bleeding.I had or will have a surgery or heart procedure 30 days before or 60 days after getting an implant.I had a major bleeding event in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Device Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Stroke Patient Testimony for trial: Trial Name: NCT04394546 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted for this clinical exploration?
"According to clinicaltrials.gov, the study is still in search of participants and was first listed on October 15th 2020 with its most recent update posted just recently, November 10th 2022."
Answered by AI
Is this an innovative trial, or have similar experiments been conducted before?
"As of now, 9 trials for the WATCHMAN FLX LAAC Device are ongoing in 165 cities and 25 countries. The initial examination was sponsored by Medtronic back in 2017 with 170 participants. After going through Phase 4 drug approval processes, 61 additional tests have been completed since then."
Answered by AI
Are there various healthcare facilities conducting this research project within the state?
"This research trial is enrolling patients across 100 different sites, with Pinnacle Health at Harrisburg Hospital in Pennsylvania, PeaceHealth Southwest Medical in Vancouver Washington and the Cleveland Clinic Foundation of Cleveland Wisconsin amongst these locations."
Answered by AI
What is the highest number of individuals that can participate in this trial?
"As mandated by the study's sponsor, Boston Scientific Corporation, 3000 suitable participants must be recruited for this trial. The medical centres responsible for carrying out this research are Pinnacle Health at Harrisburg Hospital in Pennsylvania and PeaceHealth Southwest Medical Center in Washington."
Answered by AI
What medical condition is the WATCHMAN FLX LAAC Device typically employed to address?
"The WATCHMAN FLX LAAC Device is typically utilized to treat vitamin k deficiencies, but it can also be employed for other medical purposes such as supplementing vitamins and administering antibacterial treatments to those suffering from ulcerative colitis."
Answered by AI
Have any other experiments been done with the WATCHMAN FLX LAAC Device?
"The WATCHMAN FLX LAAC Device is presently being tested in nine clinical trials, three of which are in their final phase. The primary testing centre for the device is located in Lismore, New South Wales; however other locations spanning 388 sites also serve as trial grounds."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
California
Texas
Other
How old are they?
65+
What site did they apply to?
Mercy Hospital Medical Center
Marin General Hospital
Kettering Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
I'm looking for an alternative to metropol and pradaxa. Hoping this could help my a fib and others with this problem.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Memorial Hermann Memorial City Medical Center: < 48 hours
Average response time
- < 2 Days
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