Sensing Ventricular Arrhythmias by His Bundle Leads

Withdrawn

• Conditions: Heart Failure

• Registration Number: NCT03530423
• Lead Sponsor: The Guthrie Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Status Verified: 2020-12
• Study Start: 2020-12-01
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of ventricular arrhythmia from His bundle	1 hour	During defibrillation threshold testing a lead from the His bundle to an external implantable cardiac device will be used to detect an arrhythmia

Trial Locations

Locations (1)

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States