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AtriClip LAA Exclusion Device

Phase 1

Atrial Fibrillation | Unknown | Cardiovascular |AtriCure, Inc.|Last Updated: Dec 14, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

AtriClip LAA Exclusion Device · 1 trial · 2 indications

Phase 1 1
NCT01997905Stroke Feasibility StudyAtrial Fibrillation
COMPLETED13 Analytics
PHASE1COMPLETED
Stroke Feasibility Study
Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Serious Adverse Events Within 30 Days Post-Index Procedure
30 days post-index procedure

The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).

Composite Left Atrial Appendage Placement and Exclusion Success
Immediate to 3-months post-index procedure

Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: 1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient. 2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \<10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE. 3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \< 10mm residual pocket) between the LA and LAA at \>=3 month TEE or CTA evaluation.

Secondary Endpoints

Rate of Stroke and Non-CNS Systemic Embolism
3 months and 6 months post-index procedure
Serious Device or Procedure Related Adverse Event Rate
3 month and 6 month post-index procedure
Overall Serious Adverse Event Rate
3 month and 6 month Post Index Procedure
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AtriClip LAA Exclusion DeviceEXPERIMENTALAtriClip delivered via minimally invasive surgical procedure

Interventions

NameTypeDescription
AtriClip LAA Exclusion DeviceDEVICE -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Patient is ≥ 18 years and ≤ 80 years of age. 2. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF). 3. CHADS2 or CHA2DS2VASc score ≥2. 4. Patient has medical contraindication to long term ant...

Countries:United States
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Frequently asked questions about AtriClip LAA Exclusion Device

What is AtriClip LAA Exclusion Device used for in Atrial Fibrillation?

The AtriClip LAA Exclusion Device is used for atrial fibrillation (AFib). It is a device designed to exclude the left atrial appendage (LAA), which is a common source of blood clots in patients with AFib. The device is currently in clinical development and is being studied for its potential role in stroke prevention.

Who makes AtriClip LAA Exclusion Device?

AtriClip LAA Exclusion Device is developed by AtriCure, Inc., a company traded on the stock exchange under the ticker symbol ATRC. AtriCure specializes in medical devices for the treatment of atrial fibrillation and other cardiac conditions.

What phase is AtriClip LAA Exclusion Device in?

AtriClip LAA Exclusion Device is in Phase 1 of clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The device is being studied in early-stage clinical trials to assess its safety and feasibility.

What clinical trials is AtriClip LAA Exclusion Device in?

AtriClip LAA Exclusion Device has one completed clinical trial, identified by the National Clinical Trial number NCT01997905, titled 'Stroke Feasibility Study'. This Phase 1 trial enrolled 13 participants with atrial fibrillation in the United States. The trial was not randomized, double-blind, or controlled.

Is AtriClip LAA Exclusion Device FDA approved?

AtriClip LAA Exclusion Device is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The device has completed a feasibility study, but it has not yet received regulatory approval for commercial use in the treatment of atrial fibrillation.