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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04837183
Other study ID # 20-001448
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2021
Est. completion date May 4, 2026

Study information

Verified date August 2023
Source Mayo Clinic
Contact Brian W Liddell, BS
Phone 507-255-8717
Email Liddell.Brian@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 4, 2026
Est. primary completion date May 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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).

Study Design


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in amplitude of skin sympathetic nerve activity measured in µV Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative
Primary 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
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