Persistent Atrial FibrillationNCT06858306
SPHERE Per-AF Post-Approval Study
An observational study of Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Sphere-9™ Catheter and Affera™ Ablation System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 14 sitesUnited States
- Study dates
- 25 Sep 2025to Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28230
University of Virginia Medical Center
Charlottesville, Virginia, 22903
OhioHealth
Columbus, Ohio, 43214
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901
Texas Health Resources
Fort Worth, Texas, 76104
Houston Methodist Hospital
Houston, Texas, 77030
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Montefiore Medical Center
New York, New York, 10467
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
Sarasota Memorial Hospital
Sarasota, Florida, 34239
About this study
Official title: 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.
Read the 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).
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Sphere-9™ Catheter and Affera™ Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphere-9™ Catheter and Affera™ Ablation SystemDevice
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
| Study group | Role | What they receive |
|---|---|---|
| Persistent Atrial Fibrillation | Not described Receives: Device: Sphere-9™ Catheter and Affera™ Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Objective
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Measured: 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.
Measured: Through 36 months Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start25 Sep 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858306
- Sponsor's protocol ID
- SPHERE Per-AF PAS
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
- ClinicalTrials.gov ID
- NCT06858306
- Acronym / sponsor ID
- SPHERE Per-AF PAS
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent Atrial Fibrillation | – | Device: Sphere-9™ Catheter and Affera™ Ablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphere-9™ Catheter and Affera™ Ablation SystemDe novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System | Device | Persistent Atrial Fibrillation |
Primary outcome
Primary Safety Objective
Time frame: Through 180 days Post-Procedure
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Primary Effectiveness Objective
Time frame: Through 36 months Post-Procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Objective (time frame: Through 180 days Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.