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Oral Anticoagulation
Lambre Device for Atrial Fibrillation (CORRAL-AF Trial)
N/A
Waitlist Available
Led By Brian O'Neill, MD
Research Sponsored by Brian O'Neill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or flutter
The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 5 years
Awards & highlights
CORRAL-AF Trial Summary
This trial is testing a new device to help people with atrial fibrillation who are at risk for stroke or embolism. The goal is to show that it is safe and effective.
Who is the study for?
This trial is for adults with non-valvular atrial fibrillation at increased risk of stroke, who have a CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3 and are recommended for oral anticoagulation therapy. Candidates should be able to follow the study protocol and provide consent. Exclusions include recent stroke, certain heart conditions, planned surgeries, pregnancy, other clinical trials participation, severe infections or heart failure.Check my eligibility
What is being tested?
The LAmbre PlusTM device's safety and effectiveness in preventing strokes in patients with irregularly shaped appendages is being tested against standard oral anticoagulants like warfarin and dabigatran. The goal is to find a non-pharmacologic alternative for those suitable for short-term OAC but needing long-term solutions.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from the implant procedure such as bleeding or infection; allergic reactions to device materials; interference with heart function; and risks associated with stopping oral anticoagulants if transitioning to the device.
CORRAL-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...
I am recommended for blood thinner treatment due to my stroke risk score.
CORRAL-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of time to first occurrence of ischemic stroke or systemic embolism
Composite of time to first occurrence of stroke, cardiovascular death, or clinically relevant major or non-major bleeding events
Overall safety
Secondary outcome measures
All CNS injury and dysfunction
Bleeding Complications
Closure success
+12 moreCORRAL-AF Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Roll-in ArmExperimental Treatment1 Intervention
225 roll-in subjects
Group II: Device ArmExperimental Treatment1 Intervention
The LAmbre PlusTM Left Atrial Appendage Closure System (LAmbre device)
Group III: Control ArmActive Control1 Intervention
Market approved oral anticoagulation (OAC)
Find a Location
Who is running the clinical trial?
Brian O'NeillLead Sponsor
Brian O'Neill MDLead Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.Industry Sponsor
36 Previous Clinical Trials
4,551 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My atrial fibrillation was temporary or caused by a specific condition.I have not had a stroke, mini-stroke, or heart attack in the last 3 months.I have a type of irregular heartbeat not caused by a heart valve issue.I am not pregnant or nursing and do not plan to become pregnant within a year.Your heart's left atrial appendage is suitable for the WATCHMAN device to be implanted based on its size and shape.I currently have an infection in my blood.I have no physical heart conditions that would prevent a specific heart procedure.I have severe heart failure.Your heart's pumping ability is very weak, less than 25%.You have a blood clot or abnormal heart echo seen on a recent test.I need long-term medication to prevent blood clots.My doctor thinks short-term blood thinners are okay for me, but we're looking for a non-drug option.I cannot take blood thinners due to bleeding risks or personal choice.I have a high-risk hole in my heart with significant movement or a large passage of bubbles.I have carotid artery disease but it's either not causing symptoms or has been treated so it's less severe.I am an adult over 18 and not pregnant.I am recommended for blood thinner treatment due to my stroke risk score.I am waiting for or have had an organ transplant.You have known allergies or reasons not to take aspirin, clopidogrel, heparin/bivalirudin, or certain materials used in medical devices.I have had or will have a surgery or heart procedure within 2 months.I have a tumor inside my heart.I am willing and able to follow the study's treatment and check-up schedule.I need long-term blood thinners for a condition that is not atrial fibrillation.The size of a specific area in the heart is either too big or too small according to the manufacturer's instructions.I cannot have a CT scan.I have a serious heart valve problem or a mechanical valve.My heart's mitral valve is significantly narrowed.You have severe plaque buildup in certain parts of your aorta.My doctor and I agree that I am a good candidate for LAA closure.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Device Arm
- Group 3: Roll-in Arm
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 researchers still accepting new participants for this trial?
"According to the clinicaltrials.gov portal, this trial is not currently in search of participants; it was first posted on April 1st 2022 and last modified February 15th 2022. Despite that, 652 other trials are presently enrolling patients."
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