SPHERE Per-AF Post-Approval Study

Launched by MEDTRONIC CARDIAC ABLATION SOLUTIONS · Mar 3, 2025

Keywords

ClinConnect Summary

The SPHERE Per-AF Post-Approval Study is a clinical trial designed to learn more about a new treatment for people with persistent atrial fibrillation (AF), which is a type of irregular heartbeat. This study will use the Sphere-9™ Catheter and Affera™ Ablation System to help patients who have experienced ongoing AF symptoms and have not found relief from at least one heart medication. Participants will be followed for up to three years to see how well this treatment works.

To be eligible for the study, you should be at least 18 years old and have been diagnosed with recurrent symptomatic persistent AF that has lasted between 7 days and 12 months. You should also be willing to undergo the planned procedure using the Sphere-9™ Catheter. However, if you have had a similar heart procedure before, have a life expectancy of less than three years, or have certain heart devices, you may not be able to participate. This study is not yet recruiting participants, but it aims to provide valuable insights into a new treatment option for those struggling with persistent AF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
• • 2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
• • 3. Patient is ≥ 18 years of age
• • 4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
• • 5. Patient is willing and able to comply with study requirements and give informed consent
• Exclusion Criteria:
• • 1. Long-standing persistent AF (continuous AF sustained \>12 months)
• • 2. Prior left atrial catheter or surgical ablation
• • 3. Life expectancy \<36 months
• • 4. 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)
• • 5. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic