SPHERE Per-AF Post-Approval Study

SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Sphere-9™ Catheter and Affera™ Ablation System

Detailed Description

The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama At Birmingham Hospital
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28230
      • Atrium Health Carolinas Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Health Cardiology
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Health Resources
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center
    • Lynchburg, Virginia, United States, 24501
      • Centra Medical Group Stroobants Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persistent Atrial Fibrillation	Device: Sphere-9™ Catheter and Affera™ Ablation System; De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Objective	Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.	Through 180 days Post-Procedure
Primary Effectiveness Objective	Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System.	Through 36 months Post-Procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: SPHERE Per-AF PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes