Active Clinical Trials

TRAC-AF Registry

Devices: AtriCure Isolator® Synergy™ Surgical Ablation System and AtriClip® LAA Exclusion System

• Protocol Title: Tracking Results of Ablations to Combat AF Registry (TRAC-AF)
• Study Design: Retrospective and prospective, multicenter, US/OUS, open-label, observational data registry.
• Objective: To collect long and short-term arrhythmia (atrial fibrillation) and/or stroke outcomes after undergoing one of these cardiac procedures: open concomitant, hybrid totally thoracoscopic, hybrid convergent or left atrial appendage management
• Number of Subjects and Sites: 5602 patients as of June 2022 with continued enrollment year over year at more than 38 sites
• Patient Population: Adult patients, ≥ 18 years of age, with a history of paroxysmal (intermittent) or persistent or long-standing Afib and who have undergone or will undergo ablation treatment with Maze IV ablation procedures

ClinicalTrials.gov: NCT05111015
Publication available
View TRAC-AF Registry Brochure

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 (Afib)
• 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 Afib 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 Afib patients with no Afib 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: NCT05393180

DEEP Pivotal Study

Device: AtriCure Bipolar System and AtriClip PRO LAA Exclusion System

• Protocol Title: 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 an epicardial ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power-controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.
• 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.

ClinicalTrials.gov: 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 During Concomitant On-Pump Endo/Epicardial Cardiac Surgery (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

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

FREEZE-AFIB

Device: AtriCure cryoICE cryoFORM (CRYOF) cryoablation probe, and Cryo Module 

• Protocol Title: Long-term Follow-up on LAA Exclusion using AtriClip device
• Study Design: Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the safety and long-term performance of CRYOF during concomitant Afib ablation
• Objectives: To evaluate the safety and performance of CRYOF probe. The performance 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 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.

ClinicalTrials.gov: NCT05089877

V-Clip Post Market Study

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

• Protocol Title: V-Clip Post Market Study 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

ClinicalTrials.gov: NCT05101993

aMAZE

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

• Protocol Title: Left Atrial Appendage Ligation with the LARIAT^TM 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 (Afib)
• Objectives: To demonstrate the ability of the LARIAT^TM 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 Afib; (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 Afib subjects for whom a catheter ablation procedure is planned; and (3) assess freedom from episodes of Afib > 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 Afib (< 3 years continuous Afib 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.

aMAZE Continued Access Protocol (CAP)

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

• Protocol Title: Left Atrial Appendage Ligation with the LARIAT 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, multicenter expanded use evaluation of the LARIAT^® Suture Delivery Device
• 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 52 enrolled subjects at 55 sites
• Patient Population: Subjects with documented symptomatic persistent or longstanding persistent atrial fibrillation defined as having < 3 years continuous Afib duration in whom a catheter ablation procedure is planned

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

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.

ClinicalTrials.gov identifier: NCT05280093
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.

IST Registry

Devices: AtriCure Isolator® Synergy™ Clamp, Isolator® Linear Pen, Isolator® Transpolar Pen, Lumitip® Dissection System with Glidepath™ soft guide (patients to be treated with one or more of these devices)

• Protocol Title: Inappropriate Sinus Tachycardia (IST) Registry
• Study Design: Retrospective and prospective, multicenter, US/OUS, open-label, observational data registry.
• Objective: The IST registry is established to collect real-world safety and performance data when registry sites perform a hybrid cardiac ablation procedure to treat Inappropriate Sinus Tachycardia (IST) or Postural Orthostatic Tachycardia Syndrome (POTS) which includes the use of one or more AtriCure devices to ablate cardiac tissue.
• Number of Subjects and Sites: Anticipated a minimum of 500 patients at up to 40 sites with the U.S. and Europe.
• Patient Population: Subjects ≥ 18 years who are scheduled to undergo or has undergone a hybrid ablation procedure to treat IST or POTS using one or more AtriCure devices

ClinicalTrials.gov: NCT05107635

REDUCE Registry

Devices: AtriCure Cryo Nerve Block family of devices

• Protocol Title: The Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves Registry
• Study Design: Retrospective and prospective, multicenter, US/OUS, open-label, observational registry
• Objective: To record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management
• Number of Subjects and Sites: A minimum of 100 subjects are aimed to be enrolled annually at a minimum of 10 sites
• Patient Population: Patients ≥ 18 years of age who are scheduled to undergo or have undergone cryo nerve block procedure as post operative pain management

ClinicalTrials.gov: NCT05110989
Publication available