Recent Updates
Recently added Catalysts

AtriClip LAA Exclusion Device

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01997905Stroke Feasibility StudyPHASE1 COMPLETED 13Jan 1, 2014Aug 1, 2015Dec 14, 20167 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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 -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria