NCT06858306Active, not recruiting
SPHERE Per-AF Post-Approval Study
SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 26 Feb 2025
- Start date
- 25 Sept 2025
- Primary completion date
- Oct 2030
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Diseases
- Atrial fibrillation
- NCT number
- NCT06858306
What you commit to
- Study type: Observational
- Planned participants: 200
- From 25 Sept 2025 to the primary completion date, Oct 2030
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial catheter or surgical ablation
- 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
Other illness
- 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)
Other
- Long-standing persistent AF (continuous AF sustained \>12 months)
- Life expectancy \<36 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Heart Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama At Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Atrium Health - Carolinas Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Virginia Medical Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| OhioHealth Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Doylestown Health Cardiology Coordinator of this site? Confirm its status | Doylestown | United States | Unknown status |
| Texas Health Resources Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Centra Medical Group Stroobants Cardiovascular Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Sarasota Memorial Hospital Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.