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NCT03530423 Clinical Trial

Sensing Ventricular Arrhythmias by His Bundle Leads

Heart Failure Clinical Trial

Official title:
Sensing Ventricular Arrhythmias by His Bundle Leads

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03530423
Other study ID # 1804-20
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 2021

Study information
Verified date December 2020
Source The Guthrie Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this trial is to determine if implantable cardiac device leads implanted in the His bundle are capable of detecting ventricular arrhythmias.

Description:

During routine testing of implanted leads, the His bundle lead will be connected to a separate device with all therapies disabled. Testing will be done to see if the His bundle lead can detect ventricular arrhythmias.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead. Exclusion Criteria: - Individuals with contraindications to defibrillation threshold testing

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Robert Packer Hospital Sayre Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of ventricular arrhythmia from His bundle During defibrillation threshold testing a lead from the His bundle to an external implantable cardiac device will be used to detect an arrhythmia 1 hour
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