Clinical Trials - Patients

This page contains information about clinical trials that are sponsored by AtriCure, Inc. and nContact Surgical, Inc. If you wish to learn more about any of AtriCure’s sponsored clinical trials, please visit ClinicalTrials.gov by clicking the identifer number listed within each 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, not recruiting
    • 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

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

    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, not recruiting
    • 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, not recruiting
    • 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: Up to 100 subjects / up to 5 sites
    • Patient Population: Patients age 18-85 years, undergoing unilateral thoracotomy cardiac procedures

    ClinicalTrials.gov identifier: NCT02922153

     

     

    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.