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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: 153 subjects treated at 27 sites (25 USA and 2 UK) 
  • 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.

CONVERGE Post Approval Study (PAS)

Device: EPi-Sense®-AF Guided Coagulation System

  • Protocol Title: Hybrid Convergent of Epicardial RF Ablation and Endocardial Ablation for the Treatment of Symptomatic Long-Standing Persistent Atrial Fibrillation (AF)
  • Study Design: Multi-center, prospective, open label, single arm Post Approval Study
  • Objectives: To evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense Guided Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD
  • Number of Subjects and Sites: Up to 325 subjects at up to 50 sites US, UK, and EU
  • Patient Population: 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: NCT05393180

DEEP Pivotal Study

Device: AtriCure Bipolar System

  • Protocol Title: Pivotal trial of a Dual Epicardial & Endocardial Procedure (DEEP) approach for treatment of subjects with persistent or long-standing 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 long-standing 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: Up to 220 subjects at up to 35 sites (30 USA and 5 EU)
  • Patient Population: Patients age > 18 and ≤ 75 with symptomatic persistent Afib or long-standing 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

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

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: Up to 150 treated subjects at up to 20 sites
  • Patient Population: Patients presenting with persistent or long-standing persistent atrial fibrillation scheduled to undergo an open concomitant on-bypass cardiac surgery

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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 Long-standing 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 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 long-standing persistent atrial fibrillation (AF)
  • Objectives: To demonstrate the ability of the LARIATTM Suture Delivery System to: (1) 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 long-standing persistent 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 long-standing 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: 600 randomized subjects at up to 65 sites
  • Patient Population: Subjects with documented symptomatic persistent or long-standing persistent AF (< 3 years continuous AF duration) in whom a catheter ablation procedure is planned

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

aMAZE Continued Access Protocol (CAP)

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 Continued Access Protocol (aMAZE CAP)
  • Study Design: Nested, non-randomized Protocol
  • Objectives: Allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at selected investigational sites while the marketing application for the LARIAT Suture Delivery System is under review by FDA
  • Number of Subjects and Sites: Up to 82 enrolled subjects at 55 sites
  • Patient Population: Subjects with documented symptomatic persistent or longstanding persistent AF (< 3 years continuous AF duration) in whom a catheter ablation procedure is planned

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ClinicalTrials.gov identifier: NCT04468334
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.

Long-Term Follow-Up on LAA Exclusion using AtriClip (VClip) Device

Device: FLEX-V (ACHV) and PROV (high-force clip) Devices

  • Protocol Title: Long-Term Follow-Up on LAA Exclusion using AtriClip
  • Study Design: Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study
  • Objectives: Evaluate the long-term performance and safety of AtriClip FLEX-V LAA and PROV LAA Exclusion devices for exclusion of the LAA of the heart during concomitant cardiac procedures
  • Number of Subjects and Sites: Up to 170 enrolled subjects at 20 sites in the US, UK, and EU
  • Patient Population: Subjects who have undergone designated non-emergent, cardiac surgical procedure(s), received an AtriClip implant and who are willing to return for a follow-up LAA exclusion imaging

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ClinicalTrials.gov identifier: NCT05101993

FREEZE AFIB

Device: AtriCure cryoICE cryoFORM Device

  • Protocol Title: Long-Term Follow-Up on LAA Exclusion using AtriClip
  • Study Design: Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the safety and long-term performance of CryoF during concomitant AF ablation
  • Objectives: The primary objective of this study is to evaluate the safety and performance of cryoFORM (CRYOF) device.
  • Number of Subjects and Sites: Up to 150 patients will be enrolled at up to 20 sites in the US, UK, and EU
  • Patient Population: Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation

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ClinicalTrials.gov identifier: NCT05089877

HEAL-IST

Device: Isolator Synergy Surgical Ablation System

  • Protocol Title: Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST)
  • Study Design: Prospective, multi-center, single arm, Bayesian Adaptive Design, investigational trial for the treatment of symptomatic inappropriate sinus tachycardia (IST) in patients whose IST is refractory to or who are intolerant to rate control drugs.
  • Objectives: To evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System for the treatment of symptomatic drug refractory or drug intolerant IST.
  • Number of Subjects and Sites: Up to 142 subjects at up to 40 sites
  • Patient Population: Subjects who have symptomatic IST but are refractory or intolerant to rate control drugs and/or antiarrhythmic drugs.

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ClinicalTrials.gov identifier: NCT05280093
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-0150G-0624-G