NCT06858306

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Sep 2025Oct 2030

First Submitted

Initial submission to the registry

February 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

February 26, 2025

Last Update Submit

March 31, 2026

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Persistent Atrial Fibrillation

Device: Sphere-9™ Catheter and Affera™ Ablation System

Interventions

Sphere-9™ Catheter and Affera™ Ablation SystemDEVICE

De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System

Persistent Atrial Fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28230, United States

RECRUITING

OhioHealth

Columbus, Ohio, 43214, United States

RECRUITING

Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

ACTIVE NOT RECRUITING

Texas Health Resources

Fort Worth, Texas, 76104, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

RECRUITING

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Libby Bergmann

CONTACT

libby.bergmann@medtronic.comlibby.bergmann@medtronic.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 5, 2025

Study Start

September 25, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(14)