Sensing Ventricular Arrhythmias by His Bundle Leads

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03530423

Enrollment

Registered

2018-05-21

Start date

2020-12-01

Completion date

2021-12-31

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results