Phase 4
N=53
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT00851279 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Percentage of Participants Free From VT at 1 Year Post-Treatment — 62 percentage of participants free from VT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Magnetic irrigated ablation catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stereotaxis
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Free From VT at 1 Year Post-Treatment |
62 | — |
Summary
This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.
Eligibility Criteria
Inclusion Criteria
- Subject must be between the ages of 18 - 80 years
- Willing to provide prior written informed consent per local ethics committee guidelines
- Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia
- Able to be safely exposed to static magnetic fields
- No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields
Exclusion Criteria
- Presence of a mobile ventricular thrombus
- Inability to access the left ventricle
- Subjects must not have any contraindications to short-term anticoagulation
- Subjects must not have a life expectancy of <1 year due to a medical illness
Data sourced from ClinicalTrials.gov (NCT00851279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.