Clinical Trials

This page contains information about clinical trials that are sponsored by AtriCure, Inc. If you wish to learn more about any of AtriCure’s sponsored clinical trials, please visit ClinicalTrials.gov by clicking the identifier number listed in each clinical trial below.

CONVERGE Pivotal

Device: EPi-Sense®-AF Guided Coagulation System with VisiTrax® Technology

  • Protocol Title: Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent atrial fibrillation (AF)
  • Study Design: Investigational Device Exemption (IDE), multi-center, prospective, open label randomized 2:1 (Convergent procedure vs endocardial catheter ablation) pivotal study
  • Objectives: Evaluate the safety and efficacy of the EPi-Sense-AF Guided Coagulation System to treat symptomatic persistent AF patients, refractory or intolerant to at least one Class I and/or III AADs
    • Number of Subjects and Sites: active, enrollment closed
    • Patient Population: Persistent and Long-Standing Persistent AF patients with no AF duration limits ages >18 and ≤80 with symptomatic persistent AF refractory or intolerant to at least one Class I and/or Class III AADs

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    ClinicalTrials.gov identifier: NCT01984346
    Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.

    ATLAS

    Device: AtriClip® Left Atrial Appendage Exclusion System

    • Protocol Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures 
    • Study Design: This is a prospective, multicenter, randomized (2:1), unblinded pilot study
    • Objectives: Compare impact of postoperative atrial fibrillation (POAF) among two randomized treatment arms; patients with POAF and surgical LAA closure (using AtriClip Gillinov-Cosgrove LAA Exclusion Systems) versus patients with POAF and no surgical LAA closure; evaluate healthcare resource utilization [i.e. hospital length of stay (LOS), emergency room and/or hospital re-admissions, and costs associated with specific adverse events that may be related to atrial fibrillation]
    • Number of Subjects and Sites: active, enrollment closed
    • Patient Population: Patients without a documented history of AF but who present with a CHA2DS2- VASc of > 3 and HASBLED of > 3 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol

    ClinicalTrials.gov identifier: NCT02701062

    DEEP Pivotal

    Device: AtriCure Bipolar System

    • Protocol Title: Pivotal trial of a Dual Epicardial & Endocardial Procedure (DEEP) approach for treatment of subjects with persistent or longstanding persistent atrial fibrillation (Afib) with radiofrequency (RF) ablation
    • Study Design: Prospective, multicenter, single arm, pivotal study
    • Objectives: Establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients with persistent or longstanding persistent Afib utilizing the AtriCure Bipolar System and AtriClip PRO® LAA Exclusion System in a MIS TT epicardial ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions
    • Number of Subjects and Sites: active, recruiting up to 30 sites, 220 treated subjects
    • Patient Population: Patients age > 18 and ≤ 75 with symptomatic persistent Afib or longstanding persistent Afib refractory to a minimum of one Class I or Class III AADs, may have had up to two previous catheter ablations for the treatment of Afib

    ClinicalTrials.gov identifier: NCT02393885
    Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.

    Cryoanalgesia (FROST)

    Device: cryoICE® Cryoablation Probe (CRYO2)

    • Protocol Title: The cryoICE™ Cryoanalgesia Study for pain management in post thoracic procedures via intercostal cryoanalgesia
    • Study Design: Prospective, multicenter, randomized (3:1), blinded study 
    • Objectives: Demonstrate that intraoperative intercostal cryoanalgesia in conjunction with standard of care (SOC) provides improved analgesic efficacy in patients undergoing unilateral thoracotomy cardiac procedures as compared to current SOC. Elucidate strategies for enhanced postoperative pain management of patients at risk for postoperative pulmonary complications from unilateral thoracotomy cardiac procedures
    • Number of Subjects and Sites: active, enrollment closed
    • Patient Population: Patients age 18-85 years, undergoing unilateral thoracotomy cardiac procedures

    ClinicalTrials.gov identifier: NCT02922153

    ICE-AFIB

    Device: cryoICE® Ablation System & AtriClip® Left Atrial Appendage Exclusion System

    • Protocol Title: AtriCure cryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment (ICE-AFIB)
    • Study Design: Prospective, multicenter, single arm, Bayesian adaptive design pivotal study
    • Objectives: The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device. The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.
    • Number of Subjects and Sites: active, recruiting up to 20 sites, 150 treated subjects
    • Patient Population: Patients presenting with persistent or long-standing persistent atrial fibrillation scheduled to undergo an open concomitant on-bypass cardiac surgery

    ClinicalTrials.gov identifier: NCT03732794
    Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.


    aMAZE

    Device: LARIATTM Suture Delivery System (LARIAT System)
    Includes LARIAT+ and LARIAT RS

    • Protocol Title: Left Atrial Appendage Ligation with the LARIATTM Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation (aMAZE)
    • Study Design: Prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT Suture Delivery System to percutaneously isolate and ligate the LAA from the LA as an adjunct to planned PVI catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent AF.
    • Objectives: To demonstrate the ability of the LARIATTM Suture Delivery System to: (1) percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation (AF); (2) demonstrate that the adjunctive percutaneous LAA ligation procedure does not result in an unacceptable risk of serious adverse events (SAEs) in persistent or longstanding persistent AF subjects for whom a catheter ablation procedure is planned; and (3) assess freedom from episodes of AF > 30 seconds duration any time following the 90-day blanking period post-index PVI through 12 months post PVI.
    • Number of Subjects and Sites: active, recruiting up to 65 sites, 600 treated subjects
    • Patient Population: Subjects with documented symptomatic persistent or longstanding persistent AF (< 3 years continuous AF duration) in whom a catheter ablation procedure is planned

    ClinicalTrials.gov identifier: NCT02513797
    Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.


     

     

    The information contained on this page and/or its links are not intended to promote or otherwise commercialize unapproved devices or unapproved uses of approved AtriCure devices. 

    PE-US-0150C-1120-G