MedTrace Logo

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

NCT04211441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-05-16

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Petr Neužil, MD. PhD. · Homolka Hospital, Prague

  • Petr Peichl, MD. PhD. · Institute Klinicke a Experimentalni Mediciny

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-09-02
Completion
2020-09-18
FDA Device
Yes

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211441 on ClinicalTrials.gov