Sympathetic Ablation for Ventricular Arrhythmias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Central sympathetic nerve ablation.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia (VT). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Feasibility Study of Central Sympathetic Nerve Ablation for Treatment of Ventricular Arrhythmias
Overview
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
- Device Central sympathetic nerve ablation
Catheter-based ablation of an extra-cardiac nerve target
Primary outcome measures
- Freedom from device and procedure-related serious adverse events (SAEs) [Time frame: 3 months]
- VT burden (episodes per month) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Age 18 or older at the time of informed consent
- Willing and capable of providing written informed consent
- Implanted ICD or CRT-D
- Recurrent VT leading to ICD therapy (ATP or shock)
- Indicated for catheter ablation of VT per international guidelines
- No prior instrumentation or resection of the stellate ganglia, or surgical procedure that may have disturbed the stellate ganglia
Exclusion criteria
- Contraindication to percutaneous femoral arterial access
- Heparin-induced thrombotic thrombocytopenia
- Prior surgical sympathectomy
- ECMO therapy in the past 30 days
- Contraindicated for advanced heart failure therapies (LVAD or heart transplantation)
- A most recently documented LVEF <20% in the past 30 days
- Receiving inotropic drug therapy
- Women of childbearing potential who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test at enrollment
- A life expectancy of less than 12 months according to physician judgment
- Involvement in any concurrent clinical study with an investigational therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07501819 · SK-001