Sympathetic Ablation for Ventricular Arrhythmias

NCT07501819 | Not Yet Recruiting FDA Device

• 1 other identifier: SK-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventricular Tachycardia (VT)

Outcome Measures

Primary Outcomes (2)

• Freedom from device and procedure-related serious adverse events (SAEs)

  3 months

• VT burden (episodes per month)

  VT burden post-ablation will be compared to VT burden pre-ablation

  3 months

Study Arms (1)

Therapy

EXPERIMENTAL

Central sympathetic nerve ablation therapy

Device: Central sympathetic nerve ablation

Interventions

Central sympathetic nerve ablation DEVICE

Catheter-based ablation of an extra-cardiac nerve target

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SymKardia: lead

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Imad Libbus, PhD

CONTACT

651-242-4431; imad.libbus@symkardia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share