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RECRUITING NA

Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)

NCT06703489 · View on ClinicalTrials.gov ↗

Study Summary

Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.

Interventions

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

Study Locations (6)

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

New York

  • Icahn School of Medicine at Mount Sinai — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Tennessee

  • Vanderbilt University Medical Center — Nashville

Texas

  • Texas Cardiac Arrhythmia Research Foundation — Austin

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-03-18
Est. Completion 2027-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06703489

The ClinicalTrials.gov registry entry for NCT06703489 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ventricular Tachycardia (VT) appearing as the primary indexed condition, and to 1 intervention — of which Sphere-9 Catheter with the Affera Mapping and Ablation System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06703489 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06703489 about?

NCT06703489 is a clinical study titled "Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)". Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.

What is the current status of trial NCT06703489?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-03-18. Estimated completion is 2027-01.

What conditions does trial NCT06703489 study?

This clinical trial studies the following conditions: Ventricular Tachycardia (VT). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06703489?

The interventions under investigation include: Sphere-9 Catheter with the Affera Mapping and Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06703489?

This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06703489 being conducted?

This trial has 6 study locations across Massachusetts, New York, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial