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Left Atrial Appendage Closure Device
CLAAS Device for Atrial Fibrillation
N/A
Waitlist Available
Led By William Gray, M.D.
Research Sponsored by Conformal Medical, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk of stroke or systemic embolism, defined as CHADS2 score of >2 or CHA2DS2-VASc score of ≥ 3
Documented non-valvular AF (paroxysmal, persistent, or permanent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will evaluate a new device for safety and efficacy by comparing it to two other devices that are already available. The trial will last for 5 years.
Who is the study for?
Adults over 18 with non-valvular atrial fibrillation at high risk for stroke (CHADS2 >2 or CHA2DS2-VASc ≥3) who can't take long-term oral anticoagulants but can handle short-term use. Excludes those with recent strokes, severe heart failure, general anesthesia issues, life expectancy under 5 years, pregnancy plans within a year, certain allergies or conditions that affect device placement.Check my eligibility
What is being tested?
The trial is testing the CLAAS device against existing WATCHMAN and Amulet devices for closing the left atrial appendage in patients with atrial fibrillation to prevent strokes. Participants are randomly chosen to receive one of these devices and will be monitored for five years.See study design
What are the potential side effects?
Potential side effects may include complications from implantation like bleeding or infection, allergic reactions to device materials such as nickel or titanium, and any risks associated with taking aspirin or P2Y12 inhibitors required post-procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at high risk for stroke or blood clots.
Select...
I have a type of irregular heartbeat not caused by a heart valve issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ischemic stroke and systemic embolism
Procedure-related complications, all-cause death, major bleeding
Secondary outcome measures
All Cause Mortality
Closure Success
Myocardial Infarction
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CLAASExperimental Treatment1 Intervention
Transcatheter left atrial occluder
Group II: WATCHMAN / AmuletActive Control1 Intervention
Transcatheter left atrial occluder
Find a Location
Who is running the clinical trial?
Conformal Medical, IncLead Sponsor
3 Previous Clinical Trials
383 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
383 Patients Enrolled for Atrial Fibrillation
William Gray, M.D.Principal InvestigatorLankenau Heart Institute
3 Previous Clinical Trials
25,531 Total Patients Enrolled
Shephal Doshi, M.D.Principal InvestigatorPacific Heart Institute
1 Previous Clinical Trials
576 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
576 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition that requires closing a hole in my heart.I cannot undergo certain heart imaging tests due to my condition.My heart's pumping ability is severely reduced.I need long-term blood thinners for a condition other than atrial fibrillation.I have a bleeding disorder or cannot take blood thinning medications.I am at high risk for stroke or blood clots.You have a medical condition that prevents the implant from being delivered using a catheter-based system.I have a complex plaque in my heart's main artery.Your platelet or white blood cell counts are too low or too high.I had a heart attack within the last 30 days.The site doctor and another doctor agree that closing the left atrial appendage is the right choice for you, and they make this decision together based on standard medical practices.I have had or will have a surgery or intervention within 2 months around my procedure.I have a high-risk hole in my heart with significant movement or a large leak.I have had a stroke or a mini-stroke in the last 30 days.My kidney function is low, with an eGFR below 30 mL/min.Your heart's left atrial appendage is not shaped in a way that can fit the study device or a similar device available for use.My heart's mitral valve is significantly narrowed.I do not have any physical heart conditions that would prevent a specific heart procedure.I have had symptoms from a narrowed carotid artery but less than 50% narrowing if treated before.I cannot have surgery that requires being put to sleep.I have a significant fluid buildup around my heart or symptoms of heart sac inflammation.I have a type of irregular heartbeat not caused by a heart valve issue.I am allergic to aspirin, heparin, nickel, titanium, or certain medications.You have a current, confirmed infection.My doctor thinks short-term blood thinner pills are okay for me but not long-term.My atrial fibrillation was caused by a temporary condition.You have a blood clot in your heart, as seen on a special heart imaging test.My cancer has spread to my heart.I have reasons to avoid long-term blood thinner pills.I have severe heart failure.I am an adult over 18 and not pregnant.You have had a heart transplant, mitral valve replacement surgery, or a transcatheter mitral valve intervention, or have a mechanical valve implant.
Research Study Groups:
This trial has the following groups:- Group 1: CLAAS
- Group 2: WATCHMAN / Amulet
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous locations in Canada administering this research?
"This medical study is currently recruiting from a dozen different institutions, including Ascension St. Vincent's Jacksonville in Jacksonville and The Christ Hospital in Cincinnati among others."
Answered by AI
What is the chief purpose of this experiment?
"The primary outcome for this Conformal Medical, Inc sponsored clinical trial is Ischemic stroke and systemic embolism which will be monitored over a 12 month period. Other secondary objectives include Major safety events (a composite of mortality, CNS injury, and major bleeding) measured through 18 months; Neurologic Events such as strokes or TIAs; and All Cause Mortality including cardiovascular deaths evaluated during the same timeframe."
Answered by AI
Is the enrollment period of this research study ongoing?
"According to information found on clinicaltrials.gov, this study has ceased recruiting patients since it was last modified on October 11th 2022. Initially posted in May 26th of the same year, no more participants are being sought after for this particular trial; however there are 1471 other trials that urgently need volunteers at present."
Answered by AI
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