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NCT06703489 · ClinicalTrials.gov registry record · NA
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
A NA study of Ventricular Tachycardia (VT), sponsored by Medtronic Cardiac Ablation Solutions.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 6
- Study locations
NCT06703489: Recruiting NA study of Ventricular Tachycardia (VT), sponsored by Medtronic Cardiac Ablation Solutions.
NCT06703489 is a NA study of Ventricular Tachycardia (VT) that is actively recruiting participants, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06703489, a NA study of Ventricular Tachycardia (VT), is actively recruiting participants, sponsored by Medtronic Cardiac Ablation Solutions.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-18 |
| Est. Completion | 2027-01 |
| Phase | NA |
What NCT06703489 shows while recruiting
NCT06703489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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.
NCT06703489 lists 6 locations in 6 states (Massachusetts, New York, Ohio).
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).
What interventions are being tested in trial NCT06703489?
The interventions under investigation include: Sphere-9 Catheter with the Affera Mapping and Ablation System (DEVICE).
Who is sponsoring clinical trial NCT06703489?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06703489's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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