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

NCT04211441 | Completed Results FDA Device

• 1 other identifier: CP-00001-E
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation; Atrial Flutter; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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 chambers * manipulation of catheter * completion of mapping procedure * safe 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 Outcomes (2)

• Percentage of Subjects Free From Documented Recurrence

  12 months

• Number of Patients With Durable Ablation Lesions at Remapping Procedure

  3 months

Study Arms (1)

Subjects who are treated with the Sphere-9™ Catheter

EXPERIMENTAL

Device: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Interventions

Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System DEVICE

Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Subjects who are treated with the Sphere-9™ 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:

• Age ≥ 18 and \< 75 years.
• 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.
• 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.
• Subject is able and willing to give informed consent.
• Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

You may not qualify if:

• Documented thrombus or another abnormality which precludes catheter introduction.
• Documented ejection fraction (EF) \< 40% for AF and AFL, and EF \< 15% for VT.
• Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant \[NOAC\]).
• Unstable angina or ongoing myocardial ischemia.
• Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
• Congenital heart disease where the underlying abnormality increases the risk of the ablation.
• Pulmonary hypertension (mean pulmonary artery pressure \[mPAP\] \> 50 mmHg)
• Enrollment in any other ongoing study protocol that would interfere with this study.
• Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) \< 29ml/min.
• Active gastrointestinal (GI) bleeding.
• Active infection or sepsis.
• Short life expectancy (\< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
• Significant anemia (defined as hemoglobin \< 8.0 gr/dL).
• Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) \> 200 mm Hg within last 30 days.
• Severe bleeding, clotting or thrombotic disorder.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (2)

Homolka Hospital

Prague, Czechia

Location

Institute Klinicke a Experimentalni Mediciny

Prague, Czechia

Location

Related Publications (2)

• 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.

  PMID: 30943762 BACKGROUND

• 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.

  PMID: 31347223 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Medtronic, Inc

medttroniccastrials@medtronic.com

800-328-2518

Study Officials

• Petr Neužil, MD. PhD.

  Homolka Hospital, Prague

  PRINCIPAL INVESTIGATOR

• Petr Peichl, MD. PhD.

  Institute Klinicke a Experimentalni Mediciny

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: December 22, 2019
• First Posted: December 26, 2019
• Study Start: June 1, 2018
• Primary Completion: September 2, 2019
• Study Completion: September 18, 2020
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)