Trials with Results

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
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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 3-month documented history of Afib while control subjects were not in Afib at the time of surgery.

ClinicalTrials.gov identifier: NCT00566787

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
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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.

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

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

aMAZE

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 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 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 was planned

ClinicalTrials.gov identifier: NCT02513797
Caution: Treatment of patients with non-paroxysmal Afib with the LARIAT Suture Delivery System is Investigational.

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: Treatment of patients with symptomatic persistent or long-standing persistent atrial fibrillation with the Lariat Suture Delivery System is Investigational.

ATLAS

Device: AtriClip Left Atrial Appendage Exclusion system

• Protocol Title: AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
• Study Design: Prospective, multi-center, randomized 2:1 (2 with AtriClip to 1 without AtriClip) pivotal study
• Objectives:
  • To compare impact of post-operative atrial fibrillation (Afib) among two randomized treatment arms: patients with post-operative Afib and surgical left atrial appendage (LAA) closure (using AtriClip Gillinov-Cosgrove LAA Exclusion Systems) as compared to patients with post-operative Afib and no surgical LAA closure.
  • To evaluate hospital length of stay, emergency room and/or hospital re-admissions, and costs associated with specific adverse events that may be related to Afib. Subjects who developed post-operative Afib and who received the AtriClip were followed for 1 year after the index procedure.
• Number of Subjects and Sites: 562 subjects at 22 U.S. sites
• Patient Population: Patients ages >18 years of age without documented preoperative Afib, a CHA2DS2-VASc score of > 3, who are scheduled for any non-mechanical valve and/or coronary artery bypass graft (CABG) procedure where direct access to the LAA was expected.

ClinicalTrials.gov identifier: NCT02701062
Trial with Results

EXCLUDE

Device: AtriClip Left Atrial Appendage Exclusion System

• Protocol Title: Exclusion of the Left Atrial Appendage with the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
• Study Design: Prospective, multi-center, single arm registry
• Objective: To demonstrate the safety and efficacy study of the LAA Exclusion Device (Clip) for the exclusion of the LAA epicardial tissue approximation
• Number of Subjects and Sites: 70 patients at 7 U.S. sites
• Patient Population: Subjects ≥ 18 years of age, with any one of the following risk factors and thought to benefit from LAA occlusion: CHADs score >2, >75 years, hypertension and age >65 years, previous stroke, history of atrial fibrillation (any classification)

ClinicalTrials.gov identifier: NCT00779857
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Stroke Feasibility Trial

Device: AtriClip Left Atrial Appendage Exclusion System

• Protocol Title: Stroke Feasibility Trial
• Study Design: Prospective, multi-center, single arm registry
• Objective: To demonstrate feasibility of deploying the AtriClip Left Atrial Appendage Exclusion System for stroke prophylaxis in patients with non-valvular Atrial Fibrillation (Afib) and in whom long term oral anticoagulation therapy is contraindicated
• Number of Subjects and Sites: 13 patients at 7 U.S. sites
• Patient Population: Subjects ≥ 18 and ≤ 80 years of age of age, with non-valvular Afib (paroxysmal, persistent, or longstanding persistent AF), CHADS2 or CHA2DS2VASc score ≥ 2, HAS-BLED Score ≥ 3 and contraindication to long term anticoagulant therapy

ClinicalTrials.gov identifier: NCT01997905

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

FROST Trial

Device: AtriCure cryoICE cryo-ablation system

• Protocol Title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
• Study Design: Prospective, multi-center, randomized (3:1), blinded study
• Objectives:
  • To demonstrate that intraoperative intercostal cryoanalgesia in conjunction with standard of care provides improved analgesic efficacy in patients undergoing unilateral thoracotomy cardiac procedures as compared to current standard of care
  • To assess complementary strategies for enhanced postoperative pain management of patients at risk for postoperative pulmonary complications from unilateral thoracotomy cardiac procedures.
• Number of Subjects and Sites: 83 subjects (64 in the cryoNB control arm and 19 in the standard of care arm) among 4 US sites
• Patient Population: Patients ages 18-85 years, undergoing unilateral thoracotomy cardiac procedure

ClinicalTrials.gov identifier: NCT02922153
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