Atrioventricular BlockRVpacingNCT01922518
Impact of Right Ventricular Pacing Determined by Electrocardiography
A study testing Septal pacing and Apex pacing in people with Atrioventricular Block, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block
- What is being tested?
- Septal pacing and Apex pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Jun 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrioventricular block, pacemaker scheduled
Who cannot join
- History of myocardial infarction
- Valvular heart disease (grade ≥ 2 )
- History of Left ventricular dysfunction ( ejection fraction <50% or LV dimension >60 mm in the pre-procedure echocardiogram)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial
Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.
Read the detailed description
Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.
- Conditions
- Atrioventricular Block
- Being tested
- Septal pacing, Apex pacing
- Keywords
- atrioventricular block, cardiomyopathy
- Medical subject headings
- Atrioventricular Block, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal pacingProcedure or surgery
Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
Apex pacingProcedure or surgery
Put RV lead around the apex
| Study group | Role | What they receive |
|---|---|---|
| Septal pacing group | Active comparator | Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis Receives: Procedure: Septal pacing |
| Apex pacing group | Active comparator | Put RV lead around the apex Receives: Procedure: Apex pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
> 10% decrease of ejection fraction
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong seog Oh, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922518
- Sponsor's protocol ID
- SeoulStMary-RVP
- Acronym
- RVpacing
- Status last verified
- Apr 2024
- First submitted
- 4 Jul 2013
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim SH, Oh YS, Nam GB, Choi KJ, Park JS, Park SW, Park SJ, On YK, Kim JS, Shin WS, Kim JH, Jang SW, Lee MY, Kim YH, Rho TH. Paced QRS axis as a predictor of pacing-induced left ventricular dysfunction. J Interv Card Electrophysiol. 2014 Dec;41(3):223-9. doi: 10.1007/s10840-014-9950-7. Epub 2014 Nov 8.
PubMed 25380704
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01922518
- Acronym / sponsor ID
- RVpacing / SeoulStMary-RVP
- Conditions
- Atrioventricular Block
- Keywords
- atrioventricular block, cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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.
Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.
Detailed description
Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septal pacing group | Active comparator | Procedure: Septal pacingPut RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis |
| Apex pacing group | Active comparator | Procedure: Apex pacingPut RV lead around the apex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atrioventricular block, pacemaker scheduled
Key exclusion criteria (3 listed)
- History of myocardial infarction
- Valvular heart disease (grade ≥ 2 )
- History of Left ventricular dysfunction ( ejection fraction <50% or LV dimension >60 mm in the pre-procedure echocardiogram)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Septal pacingPut RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis | Procedure or surgery | Septal pacing group |
| Apex pacingPut RV lead around the apex | Procedure or surgery | Apex pacing group |
Primary outcome
> 10% decrease of ejection fraction
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 25380704Kim SH, Oh YS, Nam GB, Choi KJ, Park JS, Park SW, Park SJ, On YK, Kim JS, Shin WS, Kim JH, Jang SW, Lee MY, Kim YH, Rho TH. Paced QRS axis as a predictor of pacing-induced left ventricular dysfunction. J Interv Card Electrophysiol. 2014 Dec;41(3):223-9. doi: 10.1007/s10840-014-9950-7. Epub 2014 Nov 8.
- Individual participant dataSharing planned: No
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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.
Yong seog Oh, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septal pacing and Apex pacing in people with Atrioventricular Block, run by Yong Seog Oh at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 23 Apr 2024. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
> 10% decrease of ejection fraction (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922518, which also lists 1 linked publication.
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 23 Apr 2024.