SPHERE Per-AF Post-Approval Study (NCT06858306) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SPHERE Per-AF Post-Approval Study
United States200 participantsStarted 2025-09-25
Plain-language summary
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
. Patient is ≥ 18 years of age
. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
. Patient is willing and able to comply with study requirements and give informed consent
Exclusion criteria
. Long-standing persistent AF (continuous AF sustained \>12 months)
. Prior left atrial catheter or surgical ablation
. 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 during the duration of this study not pre-approved by Medtronic
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since the SPHERE Per-AF study is described as a 'post-approval' study and is no longer actively recruiting, can you tell me what stage the research is in and whether the findings so far are relevant to my situation with persistent atrial fibrillation?
2This trial is measuring both safety and effectiveness as its primary goals — what specific risks or side effects are being tracked in this study that I should know about when considering this type of treatment?
3Because this is a post-approval study rather than an earlier-phase trial, does that mean there is already some established safety data on this device or procedure, and how does that compare to other options for treating persistent atrial fibrillation?
4Given that the trial is no longer enrolling patients, are there any similar or follow-up studies for persistent atrial fibrillation that I might be eligible for, or would standard treatment be a better path for me right now?
5What does the fact that this study is still active but not recruiting tell us about where the research stands — and will the results from this trial actually influence the treatment options you might recommend for my persistent atrial fibrillation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.