NCT03530423

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 29, 2022

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

May 8, 2018

Last Update Submit

March 14, 2022

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with contraindications to defibrillation threshold testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pramod Deshmukh

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 29, 2022

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)