Sympathetic Ablation for Ventricular Arrhythmias

March 24, 2026 updated by: SymKardia

Early Feasibility Study of Central Sympathetic Nerve Ablation for Treatment of Ventricular Arrhythmias

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy
Central sympathetic nerve ablation therapy
Device: Central sympathetic nerve ablation
Catheter-based ablation of an extra-cardiac nerve target

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from device and procedure-related serious adverse events (SAEs)
Time Frame: 3 months
3 months
VT burden (episodes per month)
Time Frame: 3 months
VT burden post-ablation will be compared to VT burden pre-ablation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SymKardia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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