AV BlockNCT03556189
Atrioventricular Optimization for Dual Chamber Pacemaker
A study testing Case management in people with AV Block, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- AV Block
- What is being tested?
- Case management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received or scheduled to receive permanent pacemaker due to AV block
Who cannot join
- Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (≥mild)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St Mary's Hospital
Seoul, Seo Ch-gu, 137-701
Ju Youn Kim, MD, 82-10-5482-7307, zzoo921@catholic.ac.kr
Yong Seog Oh, Ph.D
About this study
Official title: Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial
This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. The investigators designed to randomize AV block patients who already have or anticipated to receive pacemaker, into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. The primary endpoint is improvement of LV systolic function and the secondary endpoint is change in left ventricular volume, cardiac output, BNP, 6-minute walk capacity and NYHA class after one year.
Read the detailed description
It is well-known that persistent right ventricular apical pacing induces left ventricular dysfunction. The most important risk factor is the ratio of ventricular pacing so the effort to reduce pacing ratio is needed. However, almost 100% ventricular pacing is inevitable in complete atrio-ventricular block patients with implanted pacemaker. Traditionally the ventricular lead of the pacemaker is positioned in right ventricular apex and previous literatures reported that such right ventricular apical pacing impedes physiological ventricular contraction and induces left ventricular contractile dysfunction in long-term. The alternative positions of ventricular lead are right ventricular outflow tract and ventricular septum but the benefits are not yet clearly prooved. Additionally, adjusting atrio-ventricular delay is reportedto affect cardiac output by altering diastolic filling. The investigators aimed to analyze the effect of AV dealy in long-term left ventricular contractile function.
Patients over 19 years old who received or anticipated to receive permanent pacemaker due to AV block are randomized to 1:1 ratio into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. Patients with underlying LV systolic dysfunction or significant valvular heart disease are excluded. Six-minute walk test, BNP, transthoracic echocardiogram, NYHA class are examined at baseline and after one year.
- Conditions
- AV Block
- Being tested
- Case management
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementDevice
Case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram Receives: Device: Case management |
| Control: Usual care | No intervention | Usual care is provided with routine pacemaker interrogation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Measured: one year after randomization
Secondary outcomes (6)
Left ventricular end-diastolic diameter
Measured: one year after randomization
Left ventricular end-systolic diameter
Measured: one year after randomization
cardiac output
Measured: one year after randomization
BNP
Measured: one year after randomization
6-minute walking test
Measured: one year after randomization
NYHA class
Measured: one year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study startSep 2015
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV 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
- None (open label)
- Enrolment
- 70 participants (estimated)
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,PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556189
- Sponsor's protocol ID
- AV delay
- Status last verified
- Jun 2018
- First submitted
- 24 Apr 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03556189
- Acronym / sponsor ID
- AV delay
- Conditions
- AV Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Jun 2018 (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.
This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. The investigators designed to randomize AV block patients who already have or anticipated to receive pacemaker, into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. The primary endpoint is improvement of LV systolic function and the secondary endpoint is change in left ventricular volume, cardiac output, BNP, 6-minute walk capacity and NYHA class after one year.
Detailed description
It is well-known that persistent right ventricular apical pacing induces left ventricular dysfunction. The most important risk factor is the ratio of ventricular pacing so the effort to reduce pacing ratio is needed. However, almost 100% ventricular pacing is inevitable in complete atrio-ventricular block patients with implanted pacemaker. Traditionally the ventricular lead of the pacemaker is positioned in right ventricular apex and previous literatures reported that such right ventricular apical pacing impedes physiological ventricular contraction and induces left ventricular contractile dysfunction in long-term. The alternative positions of ventricular lead are right ventricular outflow tract and ventricular septum but the benefits are not yet clearly prooved. Additionally, adjusting atrio-ventricular delay is reportedto affect cardiac output by altering diastolic filling. The investigators aimed to analyze the effect of AV dealy in long-term left ventricular contractile function.
Patients over 19 years old who received or anticipated to receive permanent pacemaker due to AV block are randomized to 1:1 ratio into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. Patients with underlying LV systolic dysfunction or significant valvular heart disease are excluded. Six-minute walk test, BNP, transthoracic echocardiogram, NYHA class are examined at baseline and after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Case managementcase management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram |
| Control: Usual care | No intervention | –Usual care is provided with routine pacemaker interrogation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Received or scheduled to receive permanent pacemaker due to AV block
Key exclusion criteria (1 listed)
- Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (≥mild)
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 |
|---|---|---|
| Case managementCase management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram | Device | Experimental |
Primary outcome
Left ventricular ejection fraction
Time frame: one year after randomization
6 secondary outcomes
Left ventricular end-diastolic diameter
Time frame: one year after randomization
Left ventricular end-systolic diameter
Time frame: one year after randomization
cardiac output
Time frame: one year after randomization
BNP
Time frame: one year after randomization
6-minute walking test
Time frame: one year after randomization
NYHA class
Time frame: one year after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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AVEIR DR Coverage With Evidence Development (CED) Study
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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,PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with AV 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 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: status not confirmed, as of the sponsor's last update on 14 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Seog Oh, MD,PhD (82-2-2258-6035, oys@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: one year after randomization). 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 14 Jun 2018.