The primary objective of CONVERGE PAS is 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 or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III Antiarrhythmic drugs (AADs).
Official Title
CONVERGE Post-Approval Study (PAS): Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
Detailed Description
In accordance with FDA’s Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency’s PMA approval of the CONVERGE pivotal trial. Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold. The CONVERGE trial was conducted to address the treat... more
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In accordance with FDA’s Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency’s PMA approval of the CONVERGE pivotal trial. Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold. The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients. The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options. A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to: Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals. Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates. Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience. Collect and report on long term outcomes of the Hybrid Convergent procedure.
Keywords
Chronic Atrial Fibrillation
Eligibility
for people 18 Years to 80 Years
Inclusion Criteria: Age = 18 years and < 80 years at time of enrollment consent; Left atrium = 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality; Refractory or intolerant to at least one AAD (class I and/or III); Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF); Life expecta... more
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Inclusion Criteria: Age = 18 years and < 80 years at time of enrollment consent; Left atrium = 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality; Refractory or intolerant to at least one AAD (class I and/or III); Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF); Life expectancy > 12 months; and Provides written informed consent. Exclusion Criteria: Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure; Left ventricular ejection fraction < 35%; Pregnant or planning to become pregnant during study; Co-morbid medical conditions that limit one-year life expectancy; Previous cardiac surgery; History of pericarditis; Previous cerebrovascular accident (CVA), excluding fully resolved TIA; Patients who have active infection or sepsis Patients with esophageal ulcers strictures and varices; Patients with renal dysfunction who are not on dialysis (defined as GFR = 40); Patients who are contraindicated for anticoagulants such as heparin and coumadin; Patients who are being treated for ventricular arrhythmias; Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions; Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative); Patient has presence of thrombus in the left atrium determined by intraoperative TEE; Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis; Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study; Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results Presence of Barretts esophagitis
Daniel Logsdon, MD, is a board certified cardiothoracic surgeon with the Eisenhower Cardiothoracic Surgery Specialty Clinic in Rancho Mirage. After earning an undergraduate degree in Chemical Engineering and working in that field for several years, Dr. Logsdon didn’t find the work personally rewarding and decided to change the direction of his career and pursued a medical degree. He completed medical school at Louisiana University School of Medicine in New Orleans, and completed a residency... more
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Daniel Logsdon, MD, is a board certified cardiothoracic surgeon with the Eisenhower Cardiothoracic Surgery Specialty Clinic in Rancho Mirage. After earning an undergraduate degree in Chemical Engineering and working in that field for several years, Dr. Logsdon didn’t find the work personally rewarding and decided to change the direction of his career and pursued a medical degree. He completed medical school at Louisiana University School of Medicine in New Orleans, and completed a residency and fellowship in cardiothoracic surgery at the University of Southern California, Los Angeles.
“Pursuing a career in cardiothoracic surgery blends my engineering background with my desire to bring wellness to patients to return them to their best life, states Dr. Logsdon. “Chemical engineering was a good foundation from which to pursue medicine. I am fortunate to have found the best of both worlds.” Dr. Logsdon finds great satisfaction in being able to restore wellness and health to my patients, who usually are very ill when I first meet them.”
Dr. Logsdon relates and cares for his patients as if they were family members and includes patients’ families in the decision-making process. Fitness and nutrition are special interests of Dr. Logsdon and every patient will hear the importance of good nutrition and fitness as a key component to regaining wellness. “If my patients are not going to pursue good nutrition and fitness as part of their treatment plan, the benefits surgery can make will only be temporary.”
