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New heart ablation device under scrutiny for persistent AF

NCT ID NCT06858306

Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 adults with persistent atrial fibrillation (a type of irregular heartbeat lasting more than 7 days but less than a year) who are treated with the Sphere-9 catheter and Affera ablation system. The goal is to see how safe the procedure is and how well it prevents the return of abnormal heart rhythms over 3 years. Participants must have already tried at least one heart rhythm medication without success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sphere-9™ Catheter and Affera™ Ablation System (a device that uses heat energy to destroy tiny areas of heart tissue causing abnormal rhythms)
What this could lead to
If successful, this study could confirm that the Sphere-9 and Affera system is a safe and effective way to control persistent atrial fibrillation, helping patients stay free from irregular heartbeats for years.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The procedure carries risks like bleeding, infection, or heart damage, and some patients may still have arrhythmia recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent atrial fibrillation

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28230, United States

  • Centra Medical Group Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501, United States

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Texas Health Resources

    Fort Worth, Texas, 76104, United States

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.