Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

NCT05120193 | Completed Results DMC FDA Device

• 1 other identifier: CP-00009
• Study Type: interventional
• Target: 477
• Locations: 3 countries
• Sites: 23

Brief 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 (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  12 months

Secondary Outcomes (3)

• Energy Application Time

  Day 0

• Treatment Time

  Day 0

• Procedure Time

  Day 0

Study Arms (2)

Sphere-9 Catheter

EXPERIMENTAL

Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System

Device: Mapping and Ablation

THERMOCOOL SMARTTOUCH SF

ACTIVE COMPARATOR

THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System

Device: Mapping and Ablation

Interventions

Mapping and Ablation DEVICE

Minimally invasive catheter mapping and ablation procedure

Sphere-9 Catheter; THERMOCOOL SMARTTOUCH SF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (23)

Arrhythmia Institute at Grandview

Birmingham, Alabama, 35243, United States

Location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Naples Heart Institute

Naples, Florida, 34102, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

University of Pittsburgh Medical Center Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Nemocnice Ceske Budejovice

České Budějovice, 370 01, Czechia

Location

Institut Klinicke a Experimentani Mediciny

Prague, 140 21, Czechia

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Shamir Medical Center

Zrifin, 6093000, Israel

Location

Related Publications (3)

• Matsumoto 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. 2025 Sep 10. doi: 10.1007/s10840-025-02124-6. Online ahead of print.

  PMID: 40928625 DERIVED

• Kiehl 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.

  PMID: 39922404 DERIVED

• Anter 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.

  PMID: 38760584 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Medtronic, Inc.

medtroniccrmtrials@medtronic.com

800-328-2518

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 15, 2021
• Study Start: December 14, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: April 23, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); CZ (3); IL (1)