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 Guided Coagulation System to treat symptomatic persistent atrial fibrillation (Afib) patients, refractory or intolerant to at least one Class I and/or III antiarrhythmic drugs (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
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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
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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 evaluate the clinical outcomes in patients with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation (Afib) commercially treated with the AtriCure Synergy Ablation System during the Cox-MAZE IV procedure
- Number of Subjects and Sites: 365 patients at 40 U.S. sites
- Patient population: Patients with non-paroxysmal Afib (persistent or long-standing persistent) who underwent elective concomitant open, on-pump cardiac surgical procedure and the Cox-Maze IV ablation procedure.
ClinicalTrials.gov identifier: NCT01694563
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RESTORE SR
Device: 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 adjunct 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 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