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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
Must not have
Active infection with bacteremia
Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patient foramen ovale [PFO] surgical repair or implanted closure device, or obliterated left atrial appendage)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of irregular heartbeat not caused by a heart valve issue.
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I am recommended for blood thinner treatment due to my stroke risk score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an infection in my blood.
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I have no physical heart conditions that would prevent a specific heart procedure.
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I have severe heart failure.
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I need long-term medication to prevent blood clots.
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I have a high-risk hole in my heart with significant movement or a large passage of bubbles.
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I am waiting for or have had an organ transplant.
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I have a tumor inside my heart.
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I need long-term blood thinners for a condition that is not atrial fibrillation.
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I cannot have a CT scan.
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I have a serious heart valve problem or a mechanical valve.
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My heart's mitral valve is significantly narrowed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
All CNS injury and dysfunction
Bleeding Complications
Closure success
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
40 Previous Clinical Trials
5,447 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,856 Patients Enrolled for Atrial Fibrillation

Media Library

Apixaban (Oral Anticoagulation) Clinical Trial Eligibility Overview. Trial Name: NCT04684212 — N/A
Atrial Fibrillation Research Study Groups: Control Arm, Device Arm, Roll-in Arm
Atrial Fibrillation Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT04684212 — N/A
Apixaban (Oral Anticoagulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684212 — N/A
~1954 spots leftby Dec 2029
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