Ventricular Tachycardia (VT)
Conditions
Brief summary
Enrolled patients will undergo an acute procedure in which a catheter is inserted near the heart to ablate a sympathetic nerve, reducing signals that trigger ventricular arrhythmias.
Detailed description
The autonomic nervous system controls cardiac activity, and sympathetic hyperactivity is an important factor in triggering and sustaining cardiac arrhythmias such as ventricular tachycardia (VT). The objective of this study is to evaluate a new treatment for VT that targets a specific nerve that is part of the sympathetic system. In an acute procedure, an ablation catheter will be inserted into the femoral artery and guided to locations near the heart. Radiofrequency energy will be delivered to ablate the neural targets, and the catheter will be removed. Patients will be subsequently followed to determine safety and post-ablation reduction in VT frequency.
Interventions
DEVICECentral sympathetic nerve ablation
Catheter-based ablation of an extra-cardiac nerve target
Sponsors
SymKardia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older at the time of informed consent 2. Willing and capable of providing written informed consent 3. Implanted ICD or CRT-D 4. Recurrent VT leading to ICD therapy (ATP or shock) 5. Indicated for catheter ablation of VT per international guidelines 6. No prior instrumentation or resection of the stellate ganglia, or surgical procedure that may have disturbed the stellate ganglia
Exclusion criteria
1. Contraindication to percutaneous femoral arterial access 2. Heparin-induced thrombotic thrombocytopenia 3. Prior surgical sympathectomy 4. ECMO therapy in the past 30 days 5. Contraindicated for advanced heart failure therapies (LVAD or heart transplantation) 6. A most recently documented LVEF \<20% in the past 30 days 7. Receiving inotropic drug therapy 8. Women of childbearing potential who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test at enrollment 9. A life expectancy of less than 12 months according to physician judgment 10. Involvement in any concurrent clinical study with an investigational therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device and procedure-related serious adverse events (SAEs) | 3 months | — |
| VT burden (episodes per month) | 3 months | VT burden post-ablation will be compared to VT burden pre-ablation |
Contacts
CONTACTImad Libbus, PhD
Outcome results
None listed