Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias

An Initial Assessment of Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial and Ventricular Arrhythmias

A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Ventricular Tachycardia; Atrial Flutter
• Intervention / Treatment: Device: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Homolka Hospital
  • Praha, Czechia
    • Institute Klinicke a Experimentalni Mediciny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 and < 75 years.

2. Suitable candidate for catheter non-emergent mapping and ablation of cardiac arrhythmia as follows:

   • Atrial Flutter (AFL) defined as

   o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.

   OR

   • Atrial Fibrillation (AF) defined as

   • History of symptomatic paroxysmal and/or persistent atrial fibrillation within the past year documented by EKG AND
   • Failure of at least one class I-IV drug as evidenced by recurrent symptomatic AF, or intolerable to AAD.
3. Subject is able and willing to give informed consent.
4. Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

Exclusion Criteria:

1. Documented thrombus or another abnormality which precludes catheter introduction.
2. Documented ejection fraction (EF) < 40% for AF and AFL, and EF < 15% for VT.
3. Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).
4. Unstable angina or ongoing myocardial ischemia.
5. Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
6. Congenital heart disease where the underlying abnormality increases the risk of the ablation.
7. Pulmonary hypertension (mean pulmonary artery pressure [mPAP] > 50 mmHg)
8. Enrollment in any other ongoing study protocol that would interfere with this study.
9. Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) < 29ml/min.
10. Active gastrointestinal (GI) bleeding.
11. Active infection or sepsis.
12. Short life expectancy (< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
13. Significant anemia (defined as hemoglobin < 8.0 gr/dL).
14. Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within last 30 days.
15. Severe bleeding, clotting or thrombotic disorder.
16. Uncontrolled diabetes.
17. Women who are pregnant or are not willing to use contraception for the duration of the study.
18. Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] <1)
19. Prior stroke or TIA within the last 6 months.
20. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
21. Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.

22. Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.

    Additional exclusion criteria for AF patients only:

23. Left atrial diameter of >55 mm (parasternal view).
24. Prior ablation or surgery for atrial fibrillation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects who are treated with the Sphere-9™ Catheter	Device: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System; Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a Primary Safety Event	The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 post-treatment assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment) ; valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death.	90 days
Number of Positive (Affirmative) Product Performance Responses	The primary acute product performance outcome is determined during the procedure and is defined as the following: Catheter handling sufficient to reach reasonable intended targets, as determined by the physician:catheter delivery to the desired cardiac chambersmanipulation of cathetercompletion of mapping proceduresafe removal of catheter from the subject; 3D electro-anatomical map creation and utility sufficient to aid diagnosis; Generation of acceptable acute therapeutic RF lesions	Index ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Free From Documented Recurrence	A secondary product effectiveness outcome is freedom from documented recurrence of the treated arrhythmia through the Day 365 post-treatment follow-up visit. In AF subjects, this includes freedom from documented AF, atrial tachycardia (AT), or AFL.	12 months
Number of Patients With Durable Ablation Lesions at Remapping Procedure	In AF subjects that are remapped, the number of pulmonary veins that remain isolated and the number of patients with all pulmonary veins isolated will be determined.; In all subjects that are remapped, the number of previously confirmed lines of block remaining isolated will be determined.	3 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions
• Investigators: Principal Investigator: Petr Neužil, MD. PhD., Homolka Hospital, Prague; Principal Investigator: Petr Peichl, MD. PhD., Institute Klinicke a Experimentalni Mediciny

Publications and helpful links

General Publications

• Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable Lattice Electrode Ablation Catheter: A Novel Radiofrequency Platform Allowing High Current at Low Density for Rapid, Titratable, and Durable Lesions. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007090. doi: 10.1161/CIRCEP.118.007090.
• Kitamura T, Hocini M, Bourier F, Martin R, Takigawa M, Frontera A, Thompson N, Cheniti G, Vlachos K, Martin CA, Lam A, Duchateau J, Pambrun T, Denis A, Sacher F, Derval N, Cochet H, Haissaguerre M, Jais P. Larger and deeper ventricular lesions using a novel expandable spherical monopolar irrigated radiofrequency ablation catheter. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1644-1651. doi: 10.1111/jce.14089. Epub 2019 Aug 1.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): September 18, 2020

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Atrial Flutter
• Other Study ID Numbers: CP-00001-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes