Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

Launched by KARDIUM INC. · Dec 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for atrial fibrillation (AF), a condition where the heart beats irregularly. The researchers are testing a device called the Globe Mapping and Pulsed Field Ablation System to see how safe and effective it is for mapping and treating the left atrium of the heart, which is the area often involved in AF. The trial is currently looking for participants aged between 18 and 75 who have a history of AF and are scheduled for an ablation procedure, a common treatment for this condition.

To be eligible for the trial, participants should not have certain health issues, such as serious heart problems or infections, and must not have had previous heart surgeries that could affect the study. If someone joins the trial, they can expect to undergo the ablation procedure using this new device and contribute to understanding its safety and performance. This research could help improve treatments for AF in the future, making it an important effort for those affected by this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
• • 1. Diagnosis must be confirmed within 12 months before enrollment.
• • 2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
• • 2. Subjects between 18 and 75 years of age, inclusive
• Exclusion Criteria:
• • 1. Patients who have contraindications to open heart surgery
• • 2. Patients from an Intensive Care Unit
• • 3. Patients with active systemic infection (sepsis)
• • 4. Patients who have had previous ablation in the left or right atrium
• • 5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
• • 6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
• • 7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
• • 8. Patients with New York Heart Association Class III or IV heart failure
• • 9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
• • 10. Bleeding disorder history
• • 11. Patients with a known sensitivity to anesthesia or neuromuscular block agent
• • 12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
• • 13. Myocardial infarction within the last three months
• • 14. Atrioventricular (AV) block II° or III°
• • 15. Left ventricular ejection fraction (LVEF) of less than 35%
• • 16. Unstable angina