NCT04115735

Brief Summary

His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

October 2, 2019

Last Update Submit

August 3, 2023

Conditions

Atrial FibrillationCongestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Successful recording of a His bundle potential

    The pacing lead will be connected to a standard EP recording system (GE CardioLab, LS Pro, or EP Med) a copy of the intracardiac electrograms demonstrating His bundle recording will be saved electronically.

    From beginning of procedure to the end

Secondary Outcomes (2)

  • Time necessary to record the HIS bundle

    From insertion of the pacing lead until successful measurement of HIS bundle

  • Pacing threshold

    From beginning of procedure to the end of procedure

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing permanent pacemaker implantation identified by the TriHealth Heart Institute Electrophysiologists

You may qualify if:

  • Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath

You may not qualify if:

  • Patients who are unwilling or unable to sign the informed consent Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TrIHealth

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marshall Winner, MD

    TriHealth Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

September 9, 2019

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

US(1)