STOP Persistent AF PAS

Launched by MEDTRONIC CARDIAC ABLATION SOLUTIONS · Aug 6, 2021

Keywords

ClinConnect Summary

The STOP Persistent AF Post Approval Study (PAS) is a clinical trial looking at a specific treatment for people with persistent atrial fibrillation (AF), a heart condition where the heart beats irregularly. This study is currently recruiting participants aged 18 and older who have been diagnosed with persistent AF and are scheduled to undergo a procedure called pulmonary vein isolation (PVI) using a special device called the Arctic Front™ Cardiac Cryoablation Catheter System.

To be eligible for this study, participants should not have had any previous heart ablation procedures, except for specific types, and must be willing to follow the study guidelines and give their consent to participate. If you join the study, you can expect to be monitored throughout the procedure and recovery process to help researchers understand the treatment's effectiveness and safety. This research will help improve care for individuals with this heart condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has been diagnosed with persistent AF.
• • Subject is ≥ 18 years of age or minimum age as required by local regulations.
• • Planned pulmonary vein isolation (PVI) procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter System.
• • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.
• Exclusion Criteria:
• • Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL).
• • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
• • Subject with exclusion criteria required by local law.