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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06858306
The ClinicalTrials.gov registry entry for NCT06858306 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,247-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (84% lower). The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 20 total studies on file at ClinicalTrials.gov.
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 reports 12 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.