Catheter Ablation of Ventricular Arrhythmia Reduces Skin... | NCT04837183

Studies
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

NCT04837183

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Jul 3, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Ventricular Tachycardia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was closed before its planned primary completion date because early data indicated that VT ablation had little impact on sympathetic nerve activity in short-term follow up.

Expanded Access Info

Start Date

Nov 15, 2021Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Mar 16, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2024

Last Update Posted Date

Jul 3, 2024Actual

Name	Class
Cedars-Sinai Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yong-Mei Cha, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided