Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Launched by KARDIUM INC. · Jul 15, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called the Globe® Pulsed Field System for patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). Atrial fibrillation is a common heart rhythm problem that can cause symptoms like palpitations, fatigue, and shortness of breath. The goal of the study is to see if this new system is safe and effective for people who have had AF that keeps coming back and who have not had success with at least one heart medication.
To be eligible for the trial, participants need to have been diagnosed with recurrent symptomatic paroxysmal or persistent AF and must have tried at least one heart medication that did not work or caused side effects. Unfortunately, people with certain conditions, such as long-standing AF for more than a year, recent heart issues, or those with implanted heart devices, are not eligible. If someone joins the study, they will receive the treatment and be monitored for safety and effectiveness, helping researchers understand how well this new system works for treating AF.
Gender
ALL
Eligibility criteria
- Key inclusion criteria:
- • A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- • Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
- Key exclusion criteria:
- • Long-standing persistent AF (sustained \>12 months)
- • Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- • History of thromboembolic events within the past six months
- • Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- • Any cardiac surgery within the previous six months
- • Prior left atrial ablation or surgical procedure
- • Presence of an implanted cardiac device
- • Body mass index (BMI) \>40 kg/m\^2
- • Left ventricular ejection fraction (LVEF) \<35%
- • Anterior-posterior left atrial (LA) diameter \>55mm
About Kardium Inc.
Kardium Inc. is a pioneering medical technology company dedicated to transforming the treatment of cardiac arrhythmias through its innovative solutions. With a focus on developing advanced catheter-based therapies, Kardium aims to enhance the precision and efficacy of electrophysiological procedures. The company's flagship product, the Globe catheter, leverages cutting-edge imaging and mapping capabilities to provide clinicians with real-time insights during ablation procedures. Committed to improving patient outcomes and advancing cardiovascular care, Kardium actively engages in clinical trials to validate its technologies and expand its impact within the medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Miami, Florida, United States
Doylestown, Pennsylvania, United States
Cleveland, Ohio, United States
Jacksonville, Florida, United States
Royal Oak, Michigan, United States
Baltimore, Maryland, United States
Montréal, Quebec, Canada
Birmingham, Alabama, United States
Praha, , Czechia
Jonesboro, Arkansas, United States
Bad Oeynhausen, , Germany
New York, New York, United States
Birmingham, Alabama, United States
Kaiserslautern, , Germany
San Francisco, California, United States
Vancouver, British Columbia, Canada
Berlin, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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