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

NCT05115214 | Recruiting DMC FDA Device

• 1 other identifier: CP-00013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• 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.

  Index ablation procedure

Secondary Outcomes (4)

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

  12 months

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

  Index ablation procedure

• Percentage of subjects free from documented recurrence outside of the blanking period

  12 Months

• Percentage of pulmonary veins remaining isolated at remapping

  75 days

Study Arms (1)

SpherePVI™ Catheter

EXPERIMENTAL

Subjects treated with the SpherePVI™ Catheter

Device: SpherePVI™ Catheter

Interventions

SpherePVI™ Catheter DEVICE

Affera SpherePVI™ Multi-Ablation System

SpherePVI™ Catheter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (2)

Homolka Hospital

Prague, Czechia

RECRUITING

Institute Klinicke a Experimentalni Mediciny

Prague, Czechia

RECRUITING

Related Publications (2)

• 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.

  PMID: 40294729 BACKGROUND

• 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.

  PMID: 38584468 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sandra Jacobs

CONTACT

x; sandra.jacobs@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: October 19, 2021
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)