affera clinical trial

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. With a dynamic team of strong engineers and business professionals, and world-renowned clinical partners, the company has attracted talent across the country as it continues to grow. Percentage of subjects experiencing a primary safety event. Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that the first patient was treated in the recently approved SPHERE PerAF . Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. The purpose of this study is to evaluate the safety and effectiveness of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System for the treatment of symptomatic persistent atrial fibrillation (PerAF) refractory or intolerant to drugs using radiofrequency (RF) and pulsed field (PF) ablation. For more. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug. 3. Affera, Inc. has raised $5M. Left atrial diameter >50 mm (anteroposterior). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor. Uncontrolled heart failure or NYHA Class III or IV heart failure. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH SF radiofrequency ablation catheter (control device). This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: The primary effectiveness endpoint is freedom from documented recurrence of atrial tachyarrhythmias excluding the 90-day blanking period. CEO Doron Harlev previously co-founded and served as co-CEO at Rhythmia Medical, which . Subjects treated with the SpherePVI Catheter; Clinical Trial Outcome Measures Primary Measures. When typing in this field, a list of search results will appear and be automatically updated as you type. Summary: A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI Multi-Ablation System for treating paroxysmal atrial fibrillation. Affera is developing an integrated solution to efficiently deliver durable therapy for cardiac arrhythmia patients. . Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. Acquired by Boston Scientific in 2012, Rhythmia became Boston Scientific's cardiac mapping and navigation division, where Doron served as Vice President of Product and Technology. Affera SpherePVI Multi-Ablation System; Arms, Groups and Cohorts. Multiple pre-clinical models demonstrating lesion durability as well as tissue specificity associated with pulsed field ablation, Pulsed Field Mapping: an emerging mapping modality utilizing reversible electroporation, "Point-by-Point Pulsed Field Ablation (+/- Radiofrequency Ablation) to Treat Atrial Fibrillation: A First-in-Human Trial" by, "A Lattice-Tip Focal Ablation Catheter that Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial,", "Pulsed-Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability and Safety Evaluation,", "Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability,", "Pulmonary Vein Isolation With Combination Of Radiofrequency And Pulse Field Energy Using A Novel Lattice Tip Electrode: A First In Human Trial" by, "Safety Of A Combined Radiofrequency + Pulsed Field Ablation Approach To Pulmonary Vein Isolation In A First-in-human Clinical Trial" by, "Catheter Ablation Of Scar-related Ventricular Tachycardia With A Novel Lattice Electrode Rf Ablation Catheter: A First In Human Clinical Trial" by. How much do Affera, Inc. employees earn on average in the United States? Jobs at Affera View 3 Openings View our current openings below, or e-mail talent@affera.com for more information. Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. The Affera system is not currently approved for commercial use. Any condition contraindicating chronic anticoagulation. Moderate to severe mitral valve stenosis. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. The following are also considered primary effectiveness endpoint failures: Choosing to participate in a study is an important personal decision. Who are Affera, Inc. 's competitors? When carefully conducted, they are the safest and. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. Your IP: Suitable candidate for catheter ablation. Barring any unforeseen clinical trial complications, Pulsed Field Ablation seems inevitable. "Is There Any Significant Thermal Effect During Focal Biphasic Pulse Field Ablation Of Atrial Tissue? 1. For more information, please visit www.affera.com. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The Affera system includes the Sphere-9 catheter and integrated Prism-1 mapping system to enable the rapid creation of detailed maps, as well as the versatile HexaGEN ablation system to deliver either Pulsed Field or Radiofrequency lesion sets in a variety of substrates. Affera, Inc. Newton, MA Just now Be among the first 25 applicants See who Affera, Inc. has hired for this role . Suitable candidate for catheter ablation. ( NYSE:MDT) recently revealed that it has entered into a definitive agreement to acquire Affera, a medical technology company. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has completed the acquisition of Affera, Inc. The expandable lattice tip of the company's Sphere-9 catheter and integrated Prism-1 mapping and HexaGEN ablation system enable the rapid creation of detailed maps as well as the delivery of RF and PF lesion sets in a variety of substrates. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Percent of subjects with a primary adverse event [TimeFrame:180 Days], Major vascular access complications / bleeding, Hospitalization due to cardiovascular or pulmonary AE, Percent of subjects free from primary effectiveness failure [TimeFrame:12 months], Energy application time [TimeFrame:Day 0]. Study Design Study Type: Interventional Anticipated Enrollment : 50 participants Allocation: N/A Intervention Model: Single Group Assignment Masking: Apply Now Field Clinical Specialist. Brief Summary: This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Left ventricular ejection fraction (EF) < 35%. Sphere-9 Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System, Minimally invasive catheter mapping and ablation procedure, THERMOCOOL SMARTTOUCH SF Catheter; SMARTABLATE System; CARTO 3 System, Total energy application time during the index ablation procedure, Time from start to end of energy delivery. For more information, visit www.affera.com. First enrollment comes as investors provide $75M toward an oversubscribed Series C financing. The first patient was treated at New York's Mount Sinai Hospital by Dr. Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai. NOTE: The Affera catheter can actually do both PFA and RFA (Radio Frequency Ablation). Information provided by (Responsible Party): This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. 4. Why Should I Register and Submit Results? This capability has translated to promising clinical outcome data in the initial European trials. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. Study record managers: refer to the Data Element Definitions if submitting registration or results information. "The company is building best in class clinical options for electrophysiologists and patients, positioning it to become a significant platform for the treatment of Afib. 6 Estimates state that by 2030 the number of people with AF is projected to increase by up to 70 percent. Uncontrolled heart failure or NYHA Class III or IV heart failure. Overall Status: Recruiting Start Date: 2021-10-19 Completion Date: 2023-10-19 Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure. They still used RF for the pulmonary veins. Affera is a venture-backed medical device company founded by a seasoned team of leaders in the industry. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based . Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). Why Should I Register and Submit Results? The expandable lattice tip of the company's Sphere-9 catheter and integrated Prism-1 mapping and HexaGEN ablation system enable the rapid creation of detailed maps as well as the delivery of RF and PF lesion sets in a variety of substrates. U.S. Department of Health and Human Services. The action you just performed triggered the security solution. (Clinical Trial), Subjects will be blinded to treatment assignment, Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System, Active Comparator: THERMOCOOL SMARTTOUCH SF, 18 Years to 80 Years (Adult, Older Adult), Birmingham, Alabama, United States, 35243, Jonesboro, Arkansas, United States, 72401, Santa Monica, California, United States, 90404, Washington, District of Columbia, United States, 20010, Boston, Massachusetts, United States, 02114, The Ohio State University Wexner Medical Center, Nashville, Tennessee, United States, 37232, Texas Cardiac Arrhythmia Research Foundation, Institut Klinicke a Experimentani Mediciny. WASHINGTON, DC, May 8, 2020 A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or paroxysmal atrial fibrillation (AF) and showcases a novel approach to performing point-by-point ablation to provide safe and effective patient outcomes. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Percentage of subjects experiencing a primary safety event [TimeFrame:6 months], Major vascular access complications / bleeding, Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE, Cardiac tamponade / perforation (up to 30 days), Atrio-esophageal fistula (up to 180 days), Percentage of subjects with acute procedure success [TimeFrame:Index ablation procedure], Percentage of subjects experiencing a device- or procedure-related serious adverse event [TimeFrame:12 months], Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree") [TimeFrame:Index ablation procedure], catheter delivery to the desired ablation sites, safe removal of catheter from the subject, Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used), Generation of acceptable acute ablation lesions, Percentage of subjects free from documented recurrence outside of the blanking period [TimeFrame:12 Months], Percentage of pulmonary veins remaining isolated at remapping [TimeFrame:75 days], The number of pulmonary veins that remain isolated, The number of patients with all pulmonary veins isolated, A physician's note indicating recurrent, self-terminating AF, At least two electrocardiographically documented AF episodes within 12 months prior to enrollment. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05115214. Experimental: SpherePVI Catheter. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Late-Breaking Clinical Trials - Innovation Boulevard. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held . I was part of the Affera Clinical Trial, and my doctor did the cardioablation using PFA for the posterior wall. Actual Study Start Date : Jul 22, 2021 . We are developing an innovative system to treat . The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure: Acute product performance will be evaluated during the procedure and includes the following: SpherePVI Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following: Choosing to participate in a study is an important personal decision. Able and willing to give informed consent. We are pleased to join this round and look forward to advancing this much needed treatment option for the estimated 37 million people worldwide that live with this condition. Acute illness, active systemic infection, or sepsis. January 11, 2022 Medtronic plc on Monday announced that it has inked a deal to acquire Boston-based cardiac technology firm Affera Inc. Affera develops technology aimed at treating irregular. Affera's CEO, Doron Harlev, previously co-founded and served as co-CEO at Rhythmia Medical . Click to reveal January 11, 2022 Medtronic to acquire medical technology company Affera for $925m The deal will bolster Medtronic's spectrum of advanced cardiac ablation products and accessories. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure). Documented left atrial thrombus on imaging. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Contraindication to both computed tomography and magnetic resonance angiography. See insights on Affera including office locations, competitors, revenue, financials, executives, subsidiaries and more at Craft. Atrial fibrillation (AF) is the most common type of cardiac arrhythmia, affecting an estimated 33 million people globally. Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Pretty amazing. Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure). Medtronic to Acquire Affera. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. Affera, Inc. pays an average salary of $3,614,601 and salaries range from a low of $3,140,022 to a high of $4,151,870. 62.171.159.34 Dec. 20, 2021, 08:00 AM. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Subjects treated with the SpherePVI Catheter, The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device, The secondary safety outcome is the proportion of subjects experiencing device- or procedure-related serious adverse events (SAEs) as assessed at each follow-up visit. Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1-2% of the general population. "Temperature-controlled Lattice-tip Ablation Catheter Improves Clinical Outcomes In Patients With Paroxysmal Atrial Fibrillation" by Mohit K. Turagam, et. Results: In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac . In December 2021, Affera announced the commencement of the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF. Dr. Reddy commented "SPHERE Per-AF introduces focal pulsed field ablation and is the first randomized catheter ablation IDE trial to treat persistent atrial fibrillation. . Patients affected by this arrhythmia have an increased risk of stroke and heart failure, with a significant reduction in functional capacity and quality of life. 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