PULSED AF Post-Approval Study

Launched by MEDTRONIC CARDIAC ABLATION SOLUTIONS · Aug 27, 2024

Keywords

ClinConnect Summary

The PULSED AF Post-Approval Study is a clinical trial that is looking at a new treatment for people with a heart condition called atrial fibrillation (AF), which causes an irregular heartbeat. This study will include adults aged 18 and older who have experienced symptoms from AF and have not had success with certain medications aimed at controlling their heart rhythm. Participants will undergo a procedure using the PulseSelect™ PFA System, which is designed to help restore a normal heartbeat by isolating certain areas of the heart.

If you join this study, you will be followed for up to 36 months to see how well the treatment works and to monitor your health over time. This trial is currently recruiting participants, and it is important to know that those with certain conditions, such as long-standing persistent AF or prior heart surgeries, may not be eligible. Throughout the trial, participants will need to agree to the study guidelines and provide informed consent, meaning they understand and accept the terms of being part of the study. Your participation could help improve treatment options for others with this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
• • Failure or intolerance of at least one Class I or III antiarrhythmic drug
• • Patient is ≥ 18 years of age
• • Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
• • Willing and able 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:
• • Long-standing persistent AF (continuous AF sustained \>12 months)
• • Prior left atrial ablation or left atrial surgical procedure
• • Patient with life expectancy \< 36 months
• • Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• • Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager