Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

NCT04837183 | Terminated

• 1 other identifier: 20-001448
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Change in amplitude of skin sympathetic nerve activity

  measured in µV

  Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative

• Change in LF/HF ratio

  low frequency (LF)/high frequency (HF) ratio of the skin sympathetic nerve activity

  Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative

Eligibility Criteria

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

Study Population

All patients will undergo catheter ablation to control VA recommended by current guideline.

You may qualify if:

• Patients who have non-sustained or sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes.
• The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia).
• Subjects are 18 years of age and older.

You may not qualify if:

• Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control.
• Allergic to skin patch electrodes.
• Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).

Sponsors & Collaborators

• Mayo Clinic: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

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

Study Officials

• Yong-Mei Cha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 8, 2021
• Study Start: November 15, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

US (1)