Atrial FibrillationSPHERE Per-AFNCT05120193
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
A study testing Mapping and Ablation in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 3 countries.
Trial summary
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Mapping and Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 14 Dec 2021to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.
- Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).
- Suitable candidate for catheter ablation.
- Adults aged 18 - 80 years.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
- Willing and able to provide informed consent.
Who cannot join
- Continuous AF lasting for 12 months or longer.
- AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
- Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Any carotid stenting or endarterectomy.
- Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
Show all 37Show fewer
- Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
- Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
- Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
- Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
- Documented left atrial thrombus on imaging.
- History of blood clotting or bleeding abnormalities.
- Any condition contraindicating chronic anticoagulation.
- Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
- Body mass index >40 kg/m2.
- Left atrial diameter >55 mm (anterioposterior).
- Diagnosed atrial myxoma.
- Left ventricular ejection fraction (EF) < 35%.
- Uncontrolled heart failure or NYHA Class III or IV heart failure.
- Rheumatic heart disease.
- Hypertrophic cardiomyopathy.
- Unstable angina.
- Moderate to severe mitral valve stenosis.
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- Primary pulmonary hypertension.
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal failure requiring dialysis.
- History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
- Acute illness, active systemic infection, or sepsis.
- Contraindication to both computed tomography and magnetic resonance angiography.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results.
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
- Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Known drug or alcohol dependency.
- Life expectancy less than 12 months.
- Vulnerable subject (such as a prisoner or handicapped or mentally disabled person).
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States19 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maimonides Medical Center
Brooklyn, New York, 11219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
The OhioHealth Research Institute
Columbus, Ohio, 43214
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Naples Heart Institute
Naples, Florida, 34102
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Northwell Health
New York, New York, 10075
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
AdventHealth Orlando
Orlando, Florida, 32803
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Pacific Heart Institute
Santa Monica, California, 90404
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Pittsburgh Medical Center Pinnacle Health
Wormleysburg, Pennsylvania, 17043
Czechia3 sites
Nemocnice Ceske Budejovice
České Budějovice, 370 01
Institut Klinicke a Experimentani Mediciny
Prague, 140 21
Nemocnice Na Homolce
Prague, 150 30
About this study
Official title: Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).
- Conditions
- Atrial Fibrillation
- Being tested
- Mapping and Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping and AblationDevice
Minimally invasive catheter mapping and ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| Sphere-9 Catheter | Experimental | Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System Receives: Device: Mapping and Ablation |
| THERMOCOOL SMARTTOUCH SF | Active comparator | THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System Receives: Device: Mapping and Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With a Primary Adverse Event
The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure:
Within 7 days:
- Death
- Myocardial infarction
- Phrenic nerve paralysis
- Transient ischemic attack (TIA)
- Stroke/cerebrovascular accident (CVA)
- Thromboembolism
- Major vascular access complications / bleeding
- Heart block
- Gastroparesis
- Severe pericarditis
- Hospitalization due to cardiovascular or pulmonary AE
Within 30 days:
- Cardiac tamponade / perforation
Within 90 days:
- Atrio-esophageal fistula
Within 180 days:
- Pulmonary vein stenosis
Measured: 180 Days
Percent of Subjects Free From Primary Effectiveness Failure
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures:
- Inability to isolate all targeted pulmonary veins during the index procedure.
- Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure.
- Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure.
- Documented AF/AT/AFL recurrence after the 90-day blanking period.
- Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period.
- DC cardioversion for AF/AT/AFL after the 90-day blanking period.
Measured: 12 months
Secondary outcomes (3)
Energy Application Time
Total energy application time during the index ablation procedure
Measured: Day 0
Treatment Time
Time from start to end of energy delivery
Measured: Day 0
Procedure Time
Time from start to end of venous access
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Dec 2021
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 477 participants (actual)
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
- NCT05120193
- Sponsor's protocol ID
- CP-00009
- Acronym
- SPHERE Per-AF
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2021
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mansour M, Sharma D, Kiehl EL, Nair DG, Neuzil P, Kautzner J, Osorio J, Natale A, Mountantonakis SE, Hummel JD, Amin AK, Doshi SK, Siddiqui UR, Cerkvenik J, van Bragt KA, Tarakji KG, Anter E, Reddy VY, Taigen TL; SPHERE Per-AF investigators. Impact of linear ablation in persistent atrial fibrillation using a dual-energy, wide-footprint catheter: Analysis from the SPHERE Per-AF randomized trial. Heart Rhythm. 2026 Jul;23(7):e1051-e1059. doi: 10.1016/j.hrthm.2026.01.037. Epub 2026 Feb 6.
PubMed 41655663Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2026 Apr;69(3):355-363. doi: 10.1007/s10840-025-02124-6. Epub 2025 Sep 10.
PubMed 40928625Kiehl EL, Mountantonakis SE, Mansour MC, Nair DG, Sharma D, Taigen TL, Neuzil P, Kautzner J, Osorio J, Natale A, Hummel JD, Amin AK, Siddiqui UR, Bulava A, Doshi SK, Patel CP, Greenberg YJ, Tung RH, Harlev D, Hultz P, Rosen S, van Bragt KA, Tarakji KG, Reddy VY, Anter E; SPHERE Per-AF Investigators. Operator learning curve with a novel dual-energy lattice-tip ablation system. Heart Rhythm. 2026 Jan;23(1):89-96. doi: 10.1016/j.hrthm.2025.02.006. Epub 2025 Feb 6.
PubMed 39922404Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY; SPHERE PER-AF Investigators. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024 Aug;30(8):2303-2310. doi: 10.1038/s41591-024-03022-6. Epub 2024 May 17.
PubMed 38760584
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
- ClinicalTrials.gov ID
- NCT05120193
- Acronym / sponsor ID
- SPHERE Per-AF / CP-00009
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphere-9 Catheter | Experimental | Device: Mapping and AblationSphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System |
| THERMOCOOL SMARTTOUCH SF | Active comparator | Device: Mapping and AblationTHERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.
- Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).
- Suitable candidate for catheter ablation.
- Adults aged 18 - 80 years.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (37 listed)
- Continuous AF lasting for 12 months or longer.
- AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
- Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Any carotid stenting or endarterectomy.
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 |
|---|---|---|
| Mapping and AblationMinimally invasive catheter mapping and ablation procedure | Device | Sphere-9 Catheter, THERMOCOOL SMARTTOUCH SF |
Primary outcome
Percent of Subjects With a Primary Adverse Event
Time frame: 180 Days
The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: * Death * Myocardial infarction * Phrenic nerve paralysis * Transient ischemic attack (TIA) * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Major vascular access complications / bleeding * Heart block * Gastroparesis * Severe pericarditis * Hospitalization due to cardiovascular or pulmonary AE Within 30 days: • Cardiac tamponade / perforation Within 90 days: • Atrio-esophageal fistula Within 180 days: • Pulmonary vein stenosis
Percent of Subjects Free From Primary Effectiveness Failure
Time frame: 12 months
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures: * Inability to isolate all targeted pulmonary veins during the index procedure. * Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure. * Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure. * Documented AF/AT/AFL recurrence after the 90-day blanking period. * Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period. * DC cardioversion for AF/AT/AFL after the 90-day blanking period.
3 secondary outcomes
Energy Application Time
Time frame: Day 0
Treatment Time
Time frame: Day 0
Procedure Time
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41655663Mansour M, Sharma D, Kiehl EL, Nair DG, Neuzil P, Kautzner J, Osorio J, Natale A, Mountantonakis SE, Hummel JD, Amin AK, Doshi SK, Siddiqui UR, Cerkvenik J, van Bragt KA, Tarakji KG, Anter E, Reddy VY, Taigen TL; SPHERE Per-AF investigators. Impact of linear ablation in persistent atrial fibrillation using a dual-energy, wide-footprint catheter: Analysis from the SPHERE Per-AF randomized trial. Heart Rhythm. 2026 Jul;23(7):e1051-e1059. doi: 10.1016/j.hrthm.2026.01.037. Epub 2026 Feb 6.
- Derived from this study: PubMed 40928625Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2026 Apr;69(3):355-363. doi: 10.1007/s10840-025-02124-6. Epub 2025 Sep 10.
- Derived from this study: PubMed 39922404Kiehl EL, Mountantonakis SE, Mansour MC, Nair DG, Sharma D, Taigen TL, Neuzil P, Kautzner J, Osorio J, Natale A, Hummel JD, Amin AK, Siddiqui UR, Bulava A, Doshi SK, Patel CP, Greenberg YJ, Tung RH, Harlev D, Hultz P, Rosen S, van Bragt KA, Tarakji KG, Reddy VY, Anter E; SPHERE Per-AF Investigators. Operator learning curve with a novel dual-energy lattice-tip ablation system. Heart Rhythm. 2026 Jan;23(1):89-96. doi: 10.1016/j.hrthm.2025.02.006. Epub 2025 Feb 6.
- Derived from this study: PubMed 38760584Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY; SPHERE PER-AF Investigators. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024 Aug;30(8):2303-2310. doi: 10.1038/s41591-024-03022-6. Epub 2024 May 17.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapping and Ablation in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 3 countries.
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 6 inclusion and 37 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: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Czechia, Israel. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects With a Primary Adverse Event (time frame: 180 Days). 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?
On the ClinicalTrials.gov record for NCT05120193, which also lists 4 linked publications.
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 23 Apr 2025.