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: Global retrospective and prospective, multicenter, observational, open-label, patient registry to record outcomes from patients undergoing ablations for the treatment of atrial fibrillation (Afib).
• 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: 5,600 patients as of December 2023 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 Cox-Maze IV ablation procedures
• Study Status: Enrolling

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 patients treated commercially with the EPi-Sense Guided Coagulation System who have symptomatic long-standing persistent Afib and are medically refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD)
• Number of Subjects and Sites: Up to 325 subjects at up to 50 sites in the 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 AAD
• Study Status: Enrolling

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 90 days after post-index epicardial surgical procedure.
• Number of Subjects and Sites: Up to 220 subjects at up to 35 sites (30 US 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 antiarrhythmic drugs, may have had up to two previous catheter ablations for the treatment of Afib.
• Study Status: In Follow-up

ClinicalTrials.gov: NCT02393885
Caution: Treatment of patients with persistent or long-standing persistent atrial fibrillation with the AtriCure Bipolar System and AtriClip PRO LAA Exclusion System is Investigational.

ICE-AFIB Trial

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
• Study Status: Enrollment Complete

ClinicalTrials.gov: NCT03732794
Caution: Treatment of patients with non-paroxysmal Afib with the cryoICE Ablation System and AtriClip Left Atrial Appendage Exclusion system is investigational.

FREEZE-AFIB Trial

Device: AtriCure cryoICE cryoFORM (CRYOF) cryoablation probe

• 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 atrial fibrillation (Afib) ablation
• Objectives: To gather safety and performance of the CRYOF probe and determine if device effectively eliminates persistent and long-standing persistent Afib 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 with persistent or long-standing persistent Afib who have undergone concomitant surgical Afib ablation using the CRYOF device under investigation.
• Study Status: Enrollment Complete

ClinicalTrials.gov: NCT05089877

CEASE-AF

Device: AtriCure Bipolar System

• Protocol Title: Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation versus Repeated Catheter Ablation in Persistent and Long-standing Persistent Atrial Fibrillation)
• Study Design: Prospective, Randomized (2:1 ratio) multi-center trial
• Objectives: To compare the efficacy and safety of two interventional approaches (hybrid ablation versus standard catheter ablation), in preventing the recurrence of atrial fibrillation (Afib) in symptomatic, drug refractory patients with persistent or long-standing persistent Afib.
• Number of Subjects and Sites: 146 patients at 12 sites in Europe
• Patient Population: Patients 18 to 75 years with a history of symptomatic persistent Afib and a left atrium of greater than 4 cm or long-standing persistent AF who are refractory or intolerant to at least one Class I or III antiarrhythmic drug
• Study Status: In Follow-up

ClinicalTrials.gov: NCT02695277

LeAAPS Trial

Device: AtriClip Left Atrial Appendage Exclusion System

• Protocol Title: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS)
• Study Design: Prospective, randomized-controlled, multicenter, multinational, blinded, event-driven superiority investigational device exemption trial
• Objectives: Safety and efficacy study to determine if prophylactic left atrial appendage exclusion (LAAE) will reduce occurrence of ischemic stroke or systemic embolism in cardiac surgery patients with an elevated risk of stroke and no history of atrial fibrillation (Afib) compared to patients who do not receive LAAE during cardiac surgery
• Number of Subjects and Sites: Up to 6500 subjects will be treated at up to 250 sites in the U.S., Canada, Europe, and other geographies
• Patient Population: Patients ages 18 years or older undergoing planned cardiac surgery, without a documented clinical diagnosis of Afib, who present with documented risk factors for developing AFib and ischemic stroke.
• Study Status: Enrolling

ClinicalTrials.gov: NCT05478304

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
• Study Status: Enrollment Complete

ClinicalTrials.gov: NCT05101993

aMAZE Continued Access Protocol (CAP)

Device: LARIAT^TM Suture Delivery System (LARIAT System)

• 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
• Study Status: In Follow-up

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

HEAL-IST Trial

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.
• Study Status: Enrolling

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

IST Registry

Device: AtriCure Isolator® Synergy™ Surgical Ablation System

• Protocol Title: Inappropriate Sinus Tachycardia (IST) Registry
• Study Design: Retrospective and prospective, multicenter, US/OUS, open-label, observational data registry.
• Objective: To capture real-world data on the outcome of the AtriCure Isolator synergy Surgical Ablation System (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia System (POTS) using sinus node sparing hybrid ablation procedure.
• 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 have undergone a hybrid ablation procedure to treat IST or POTS using one or more AtriCure devices
• Study Status: Enrolling

ClinicalTrials.gov: NCT05107635

REDUCE Registry

Devices: AtriCure Cryo Nerve Block family of devices

• Protocol Title: The cryoICE Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery via Cryoablation of the Intercostal Nerves Registry
• Study Design: Global retrospective and prospective, multicenter, observational, open-label, 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 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
• Study Status: Enrolling

ClinicalTrials.gov: NCT05110989
Publication available