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Left Atrial Appendage Closure Device
Left Atrial Appendage Closure Device for Atrial Fibrillation
N/A
Waitlist Available
Led By William A Gray, MD
Research Sponsored by Conformal Medical, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented non-valvular AF (paroxysmal, persistent, or permanent)
High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year, 2 years, 3 years, 4 years, 5 years
Awards & highlights
Study Summary
This trial tests a new device to seal off the left atrial appendage, a common source of blood clots in people with heart conditions.
Who is the study for?
Adults with non-valvular atrial fibrillation who need but want to avoid long-term oral anticoagulation therapy. Candidates should have a CHA2DS2-VASc score of ≥2 for men or ≥3 for women, indicating a higher risk of stroke. They must be able to follow the study's procedures and provide consent. Exclusions include pregnancy, certain heart conditions, other investigational studies participation, life expectancy under 2 years, severe kidney issues, and allergies to specific medications or device materials.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of the Conformal Left Atrial Appendage Seal (CLAAS) as an alternative to chronic oral anticoagulation in preventing stroke in patients with atrial fibrillation. It involves implanting CLAAS via catheter-based system.See study design
What are the potential side effects?
Potential side effects may include complications from general anesthesia, bleeding due to antiplatelet/anticoagulant therapy required post-implantation, allergic reactions to device materials like nickel or titanium, infection risks associated with any invasive procedure.
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...
I am at high risk for stroke, with a CHA2DS2-VASc score of 2 or more (men) or 3 or more (women).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1year, 2 years, 3 years, 4 years, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year, 2 years, 3 years, 4 years, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from major adverse events
Secondary outcome measures
Closure success
Major Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Non-valvular AF adultsExperimental Treatment1 Intervention
Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.
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Who is running the clinical trial?
Conformal Medical, IncLead Sponsor
3 Previous Clinical Trials
1,919 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
1,919 Patients Enrolled for Atrial Fibrillation
Yale Cardiovascular Research GroupOTHER
7 Previous Clinical Trials
2,862 Total Patients Enrolled
William A Gray, MDPrincipal InvestigatorMain Line Health Lankenae Heart Institute
5 Previous Clinical Trials
1,042 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or nursing and do not plan to become pregnant within a year.I am allergic to aspirin, heparin, nickel, titanium, gold, or certain medications.I cannot undergo a detailed heart scan using a throat probe.Your heart's left atrial appendage is not suitable for the CLAAS device according to the manufacturer's instructions.I have a heart condition that requires closing a hole in my heart.You have a blood vessel that can't be used to insert the implant with a catheter-based system.I have severe heart failure.Your platelet count is very low or very high, or your white blood cell count is very low.I cannot have surgery that requires being put to sleep.You have a blood clot or abnormal blood flow in your heart, as seen on a special heart imaging test within the last 2 days.I have significant fluid 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 at high risk for stroke, with a CHA2DS2-VASc score of 2 or more (men) or 3 or more (women).I am advised to take blood thinners but need a non-drug alternative.I have no physical conditions that would prevent a heart procedure.My atrial fibrillation was caused by a temporary condition.I do not have a bleeding disorder and can safely take blood thinners.I have carotid artery disease with a history of stroke or TIA, or it's severe but without symptoms.I have had or will have a surgery or intervention within 90 days around my procedure.My kidney function is very low or I am on dialysis.I have a high-risk hole in my heart with specific characteristics.I have not had a stroke or mini-stroke in the last 3 months.My heart's mitral valve is significantly narrowed.I have a complex plaque in my aorta.I have a tumor in my heart.I am an adult over 18 and not pregnant.Your heart's pumping ability is less than 30%.I am considered a good candidate for LAA closure by my doctors.I need long-term blood thinners for a condition other than atrial fibrillation.I had a heart attack in the last 60 days.I currently have an infection in my blood.I am willing and able to follow the treatment plan and check-ups.
Research Study Groups:
This trial has the following groups:- Group 1: Non-valvular AF adults
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.
How many healthcare facilities are hosting this research trial?
"Patients are being recruited for this medical trial at The Heart Hospital Baylor Plano in Plano, Texas, the Texas Cardiac Arrhythmia Institute in Austin, California and Pacific Heart Institute in Santa Monica, Arkansas. 10 additional sites have also been enlisted to participate."
Answered by AI
Are participants still being welcomed into this research effort?
"Affirmative, the information available on clinicaltrials.gov supports that recruitment is underway for this research project. It was first announced on February 22nd 2019 and its details were most recently updated October 29th 2021. 45 participants are needed from 10 different medical sites."
Answered by AI
How many volunteers are involved in this experiment?
"To fundmentally progress this trial, 45 participants must be recruited who meet all the given inclusion criteria. Potential enrollees are able to join from several medical sites such as The Heart Hospital Baylor Plano in Plano, Texas and Texas Cardiac Arrhythmia Institute in Austin, California."
Answered by AI
Who else is applying?
What site did they apply to?
The Christ Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have a hard time remembering to take the medication. I am afraid of bleeding doing my normal activities.
PatientReceived no prior treatments
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