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Trials with Results

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

CONVERGE Pivotal

Device: EPi-Sense®-AF Guided Coagulation System

  • Protocol Title: Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent atrial fibrillation
  • 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 Afib patients, refractory or intolerant to at least one Class I and/or III AADs
  • Number of Subjects and Sites: 153 subjects treated at 27 sites (25 USA and 2 UK) 
  • Patient Population: Persistent and Long-Standing Persistent Afib patients with no Afib duration limits ages >18 and ≤80 with symptomatic persistent Afib refractory or intolerant to at least one Class I and/or Class III AADs

ClinicalTrials.gov identifier: NCT01984346
Hybrid AF Therapy and Clinical Data
View Trial Results

ABLATE

Device: AtriCure Bipolar System

  • Protocol Title: AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)
  • Study Design: Prospective, non-randomized multi-center clinical trial
  • Objective: To demonstrate the safety and effectiveness of the Cox Maze IV procedure using the AtriCure Bipolar System for treating permanent atrial fibrillation (Afib) during concomitant on-pump cardiac surgery.
  • Number of Subjects and Sites: 55 subjects at 9 U.S. sites
  • Patient Population: Patients ages ≥ 18 years with a history of permanent Afib who underwent elective cardiac surgery on cardiopulmonary bypass and who had a left ventricular ejection fraction of ≥ 30% and life expectancy of ≥ 1 year.

ClinicalTrials.gov identifier: NCT00560885
View Trial Results

ABLATE PAS

Device: AtriCure Bipolar System

  • Protocol Title: ABLATE Post Approval Study – Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation (ABLATE-PAS)
  • Study Design: prospective, single arm registry multicenter study
  • Objective: To monitor the AtriCure Synergy Ablation System for continued safety and efficacy during peri-procedural and long-term phase during commercial use
  • Number of Subjects and Sites: 365 patients at 40 U.S. sites
  • Patient population: Patients with non-paroxysmal atrial fibrillation (persistent or long-standing persistent) who underwent elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure.

ClinicalTrials.gov identifier: NCT01694563
View Trial Results

RESTORE SR

Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

  • Protocol Title: Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)
  • Study Design: Prospective, multi-center, single arm registry with matched controls
  • Objective: Safety and efficacy study to evaluate the AtriCure Bipolar System for the treatment of continuous atrial fibrillation (Afib) as adjuct therapy to elective open-heart surgery
  • Number of Subjects and Sites: 39 patients at 9 U.S. sites
  • Patient Population: Subjects ≥ 18 years to ≤ 80 years of age, left ventricular ejection fraction of ≥ 30%, who are scheduled to undergo elective cardiac surgical procedure(s) on cardiopulmonary bypass. Treatment subjects had a s3-month documented history of Afib while control subjects were not in Afib at the time of surgery.

ClinicalTrials.gov identifier: NCT00566787

DEEP Hybrid

Device: AtriCure Bipolar System in conjunction with catheter ablation

  • Protocol Title: Dual Epicardial Endocardial Persistent Atrial Fibrillation Study (DEEP Hybrid)
  • Study Design: Prospective, multi-center, single arm registry
  • Objective: Feasibility trial to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating atrial fibrillation (Afib) without cardiopulmonary bypass
  • Number of Subjects and Sites: 24 patients at 4 U.S. sites
  • Patient Population: Age > 18 years with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent Afib

ClinicalTrials.gov identifier: NCT01246466
Trial has results

Staged DEEP

Device: AtriCure Bipolar System used in conjunction with catheter ablation

  • Protocol Title: Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients with Persistent or Long Standing Persistent Atrial Fibrillation with Radiofrequency Ablation (Staged DEEP)
  • Study Design: Prospective, multi-center, single arm registry
  • Objective: Safety and technical feasibility of treating subjects with persistent atrial fibrillation (Afib) or longstanding persistent Afib in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization
  • Number of Subjects and Sites: 30 patients at 6 sites in the U.S. and Europe
  • Patient Population: Subjects ≥ 18 years of age, with symptomatic persistent or longstanding persistent Afib refractory to a minimum of one Class I or III antiarrhythmic drug and failed catheter ablation attempts more than 3 months prior to index procedure

ClinicalTrials.gov identifier: NCT01661205
Trial has Results

ATLAS

Device: AtriClip Left Atrial Appendage Exclusion system

  • Protocol Title: AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
  • Study Design: Prospective, multi-center, randomized 2:1 (2 with AtriClip to 1 without AtriClip) pivotal study
  • Objectives:
    • To compare impact of post operative atrial fibrillation (POAF) among two randomized treatment arms: patients with POAF and surgical left atrial appendage (LAA) closure (using AtriClip Gillinov-Cosgrove LAA Exclusion Systems) as compared to patients with POAF and no surgical LAA closure.
    • To evaluate hospital length of stay, emergency room and/or hospital re-admissions, and costs associated with specific adverse events that may be related to atrial fibrillation (Afib). Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.
  • Number of Subjects and Sites: 562 subjects at 22 U.S. sites
  • Patient Population: Patients ages >18 years of age without documented preoperative Afib and a CHA2DS2-VASc score of > 3, who are scheduled for any non-mechanical valve and/or coronary artery bypass graft (CABG) procedure where direct access to the LAA is expected.

ClinicalTrials.gov identifier: NCT02701062
Trial with Results

EXCLUDE

Device: AtriClip Left Atrial Appendage Exclusion System

  • Protocol Title: Exclusion of the Left Atrial Appendage with the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
  • Study Design: Prospective, multi-center, single arm registry
  • Objective: To demonstrate the safety and efficacy study of the LAA Exclusion Device (Clip) for the exclusion of the LAA epicardial tissue approximation
  • Number of Subjects and Sites: 70 patients at 7 U.S. sites
  • Patient Population: Subjects ≥ 18 years of age, with any one of the following risk factors and thought to benefit from LAA occlusion: CHADs score >2, >75 years, hypertension and age >65 years, previous stroke, history of atrial fibrillation (any classification)

ClinicalTrials.gov identifier: NCT00779857
View Trial Results

Stroke Feasibility Trial

Device: AtriClip Left Atrial Appendage Exclusion System

  • Protocol Title: Stroke Feasibility Trial
  • Study Design: Prospective, multi-center, single arm registry
  • Objective: To demonstrate feasibility of deploying the AtriClip Left Atrial Appendage Exclusion System for stroke prophylaxis in patients with non-valvular Atrial Fibrillation (Afib) and in whom long term oral anticoagulation therapy is contraindicated
  • Number of Subjects and Sites: 13 patients at 7 U.S. sites
  • Patient Population: Subjects ≥ 18 and ≤ 80 years of age of age, with non-valvular Afib (paroxysmal, persistent, or longstanding persistent AF), CHADS2 or CHA2DS2VASc score ≥ 2, HAS-BLED Score ≥ 3 and contraindication to long term anticoagulant therapy

ClinicalTrials.gov identifier: NCT01997905

FROST Trial

Devices: AtriCure cryoICE cryo-ablation system

  • Protocol Title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
  • Study Design: Prospective, multi-center, randomized (3:1), blinded study
  • Objectives:
    • To demonstrate that intraoperative intercostal cryoanalgesia in conjunction with standard of care provides improved analgesic efficacy in patients undergoing unilateral thoracotomy cardiac procedures as compared to current standard of care
    • To assess complementary strategies for enhanced postoperative pain management of patients at risk for postoperative pulmonary complications from unilateral thoracotomy cardiac procedures.
  • Number of Subjects and Sites: 83 subjects (64 in the cryoNB control arm and 19 in the standard of care arm) among 4 US sites
  • Patient Population: Patients ages 18-85 years, undergoing unilateral thoracotomy cardiac procedures

ClinicalTrials.gov identifier: NCT02922153
View Trial Results

PE-US-2236A-0724-G