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Atrial FibrillationSpherePVINCT05115214

Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

A study testing SpherePVI™ Catheter in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 2 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
SpherePVI™ Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesCzechia
Study dates
19 Oct 2021to 15 Jan 2030
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic paroxysmal or persistent atrial fibrillation (PAF) documented by:
  • A physician's note indicating recurrent AF
  • At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
  • Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
  • Suitable candidate for catheter ablation.
  • Age ≥ 18 and < 75 years.
  • Able and willing to give informed consent.
  • Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.

Who cannot join

  • Subjects will not be eligible for the study if any of the following criteria are met:
  • Continuous AF lasting more than 12 months (long-standing persistent AF).
  • AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
  • Previous left atrial catheter or surgical ablation (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.
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  • Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
  • Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
  • Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.
  • Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
  • Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
  • 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 (anteroposterior) >50 mm for paroxysmal AF and >55mm for persistent AF.
  • Diagnosed atrial myxoma.
  • Left ventricular ejection fraction (EF) < 40%.
  • 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.
  • Acute illness, active systemic infection, or sepsis.
  • 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 trial 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 trial of a drug, device, or biologic during the duration of the study, unless 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Jacobs contact

x

sandra.jacobs@medtronic.com

Czechia2 sites, 2 recruiting

  • Homolka Hospital

    Prague

    Petr Neužil, MD. PhD

    Recruiting

  • Institute Klinicke a Experimentalni Mediciny

    Prague

    Petr Peichl, MD. PhD.

    Recruiting

Other trials in Czechia

About this study

Official title: A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.

Being tested
SpherePVI™ Catheter
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpherePVI™ CatheterDevice

    Affera SpherePVI™ Multi-Ablation System

Study groups in NCT05115214
Study groupRoleWhat they receive
SpherePVI™ CatheterExperimentalSubjects treated with the SpherePVI™ Catheter
Receives: Device: SpherePVI™ Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects experiencing a primary safety event

    The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure:

    • Death
    • Myocardial infarction
    • Persistent phrenic nerve palsy
    • Transient ischemic attack (TIA)
    • Stroke/cerebrovascular accident (CVA)
    • Thromboembolism
    • Major vascular access complications / bleeding
    • Heart block
    • Gastroparesis
    • Severe pericarditis
    • Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE
    • Cardiac tamponade / perforation (up to 30 days)
    • Pulmonary vein stenosis (up to 180 days)
    • Atrio-esophageal fistula (up to 180 days)

    Measured: 6 months

  2. Percentage of subjects with acute procedure success

    The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device. Acute electrical isolation of all pulmonary veins is defined as confirmation of entrance block in all targeted pulmonary veins.

    Measured: Index ablation procedure

Secondary outcomes (4)

  1. Percentage of subjects experiencing a device- or procedure-related serious adverse event

    The secondary safety outcome is the proportion of subjects experiencing device- or procedure-related serious adverse events (SAEs) as assessed at each follow-up visit

    Measured: 12 months

  2. Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree")

    Acute product performance will be evaluated during the procedure and includes the following:

    • SpherePVI™ Catheter handling sufficient to reach reasonable intended targets, as determined by the physician:
    • catheter delivery to the desired ablation sites
    • completion of ablation procedure
    • safe removal of catheter from the subject
    • Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used)
    • Generation of acceptable acute ablation lesions
    • Acute block across linear ablation lines (e.g. CTI flutter line), if performed

    Measured: Index ablation procedure

  3. Percentage of subjects free from documented recurrence outside of the blanking period

    Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter).

    Measured: 12 Months

  4. Percentage of pulmonary veins remaining isolated at remapping

    Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following:

    • The number of pulmonary veins that remain isolated
    • The number of patients with all pulmonary veins isolated
    • The number of previously ablated lines that remain blocked (when applicable)

    Measured: 75 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start19 Oct 2021
  3. Primary completion15 Sep 2029 (estimated)
  4. Study completion15 Jan 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115214
Sponsor's protocol ID
CP-00013
Acronym
SpherePVI
Status last verified
Sep 2026
First submitted
20 Oct 2021
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Reddy VY, Peichl P, Kautzner J, Anter E, Metzner A, Koruth J, Jais P, Rackauskas G, Petru J, Funasako M, Marinskis G, Turagam M, Aidietis A, Selma JM, Nejedlo V, Kueffer F, Tarakji KG, Natale A, Neuzil P. One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation. Heart Rhythm. 2025 Oct;22(10):2551-2561. doi: 10.1016/j.hrthm.2025.04.031. Epub 2025 Apr 26.

    PubMed 40294729

  • Reddy VY, Anter E, Peichl P, Rackauskas G, Petru J, Funasako M, Koruth JS, Marinskis G, Turagam M, Aidietis A, Kautzner J, Natale A, Neuzil P. First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation. Europace. 2024 Mar 30;26(4):euae090. doi: 10.1093/europace/euae090.

    PubMed 38584468

Questions about this trial

What is this clinical trial studying?

A study testing SpherePVI™ Catheter in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 2 sites in Czechia.

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 8 inclusion and 36 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. 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?

Contact Sandra Jacobs (x, sandra.jacobs@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects experiencing a primary safety event (time frame: 6 months). 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 NCT05115214, which also lists 2 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 15 Sep 2026.

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