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: 5,800 patients as of December 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 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
ClinicalTrials.gov: NCT03732794
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.
FREEZE-AFIB Trial
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