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NCT06858306 · ClinicalTrials.gov registry record
SPHERE Per-AF Post-Approval Study
A clinical trial of Persistent Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
- Recruiting
- Registry status
- 200
- Enrollment target
- 12
- Study locations
NCT06858306: Recruiting study of Persistent Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
NCT06858306 is a study of Persistent Atrial Fibrillation that is actively recruiting participants, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 200 participants, below the 1,247-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (84% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06858306, a study of Persistent Atrial Fibrillation, is actively recruiting participants, sponsored by Medtronic Cardiac Ablation Solutions.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Conditions Studied
Interventions
- DEVICE Sphere-9™ Catheter and Affera™ Ablation System
Study Locations (12)
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
- Mayo Clinic - Rochester
Pennsylvania
- Doylestown Health Cardiology - Doylestown
- Allegheny General Hospital - Pittsburgh
Texas
- Texas Health Resources - Fort Worth
- Houston Methodist Hospital - Houston
Virginia
- University of Virginia Medical Center - Charlottesville
- Centra Medical Group Stroobants Cardiovascular Center - Lynchburg
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
Florida
- Sarasota Memorial Hospital - Sarasota
New York
- Montefiore Medical Center - New York
Ohio
- OhioHealth - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2030-10 |
What NCT06858306 shows while recruiting
NCT06858306 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,247-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Persistent Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Sphere-9™ Catheter and Affera™ Ablation System is the first listed.
NCT06858306 lists 12 locations in 8 states (Minnesota, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT06858306 about?
NCT06858306 is a clinical study titled "SPHERE Per-AF Post-Approval Study". 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.
What is the current status of trial NCT06858306?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-09-25. Estimated completion is 2030-10.
What conditions does trial NCT06858306 study?
This clinical trial studies the following conditions: Persistent Atrial Fibrillation.
What interventions are being tested in trial NCT06858306?
The interventions under investigation include: Sphere-9™ Catheter and Affera™ Ablation System (DEVICE).
Who is sponsoring clinical trial NCT06858306?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06858306 being conducted?
This trial has 12 study locations across Alabama, Florida, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Persistent Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06858306's enrollment target sits among peer trials
200 10th of 15 higher than 5 of 15 other Persistent Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Persistent Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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