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

May 15, 2025 updated by: Medtronic Cardiac Ablation Solutions

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With a Primary Safety Event
Time Frame: 90 days
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
Time Frame: Index ablation procedure

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Free From Documented Recurrence
Time Frame: 12 months
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
Time Frame: 3 months
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Ablation Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Petr Neužil, MD. PhD., Homolka Hospital, Prague
  • Principal Investigator: Petr Peichl, MD. PhD., Institute Klinicke a Experimentalni Mediciny

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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