Sympathetic Ablation for Ventricular Arrhythmias

SymKardia

Status: Not yet enrolling

Conditions: Ventricular Tachycardia (VT)

Treatments: Device: Central sympathetic nerve ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07501819

SK-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Therapy

Experimental group

Description:

Central sympathetic nerve ablation therapy

Treatment:

Device: Central sympathetic nerve ablation