Atrial FibrillationNCT04115735
His Bundle Recording From Subclavian Vein
An observational study of Atrial Fibrillation and Congestive Heart Failure, run by TriHealth Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Atrial Fibrillation, Congestive Heart Failure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 23 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing permanent pacemaker implantation identified by the TriHealth Heart Institute Electrophysiologists
Who may be able to join
- 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
Who cannot join
- Patients who are unwilling or unable to sign the informed consent Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation
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.
Read the detailed description
The purpose of this prospective observational 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. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.
- Conditions
- Atrial Fibrillation, Congestive Heart Failure
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From beginning of procedure to the end
Secondary outcomes (2)
Time necessary to record the HIS bundle
Both the procedural and fluoroscopy time from insertion of the pacing lead until successful measurement of the His bundle
Measured: From insertion of the pacing lead until successful measurement of HIS bundle
Pacing threshold
Threshold will be measured in volts at 1 millisecond and recorded for selective His bundle capture, non-selective His bundle capture, and ventricular septal capture as appropriate for each patient. The measurement of a normal His Bundle threshold is < 2.0 V at 1.0 ms.
Measured: From beginning of procedure to the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start9 Sep 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Why it stopped: Enrollment not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marshall Winner, MD, Principal investigator, TriHealth Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115735
- Sponsor's protocol ID
- 18-109
- Status last verified
- Aug 2023
- First submitted
- 2 Oct 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT04115735
- Acronym / sponsor ID
- 18-109
- Conditions
- Atrial Fibrillation, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment not feasible
- Enrolment
- 1 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this prospective observational 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. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing permanent pacemaker implantation identified by the TriHealth Heart Institute Electrophysiologists
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are unwilling or unable to sign the informed consent Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful recording of a His bundle potential
Time frame: From beginning of procedure to the end
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.
2 secondary outcomes
Time necessary to record the HIS bundle
Time frame: From insertion of the pacing lead until successful measurement of HIS bundle
Pacing threshold
Time frame: From beginning of procedure to the end of procedure
Results and safety
The study was stopped early (reason given: Enrollment not feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall Winner, MD principal investigator
TriHealth Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Congestive Heart Failure, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment not feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful recording of a His bundle potential (time frame: From beginning of procedure to the end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.