Pacemaker ComplicationNCT03475498
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)
An observational study of Pacemaker Complication, run by Eulji University Hospital at 3 sites in South Korea.
Trial summary
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pacemaker Complication
- How many people
- 1,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 30 Jan 2018to 28 Feb 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll at least 1000 device patients from multi-centers in order to identify and assess a determinant of PICM and its clinical outcomes (PICM syndrome)
Who may be able to join
None listed.
Who cannot join
- Less than 18 years of age
- Being pregnant or plan to become pregnant
- Advanced heart failure waiting in heart transplantation
- Have a life expectancy of less than 1 year
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hyu Ryung Cho contact
South Korea3 sites, 3 recruiting
- Recruiting
Chung-Buk University Hospital
Chungju
Deain Lee, M.D.
- Recruiting
Chung-Nam University Hospital
Daejeon
Jun Hyung Kim, MD. PhD.
- Recruiting
Chung-Ang University Hospital
Seoul
Hyu Ryung Cho, 82-10-5180-3742, whgbfud@gmail.com
About this study
Official title: A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.
Read the detailed description
Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM
- Conditions
- Pacemaker Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure diagnosis and treatment
Occurrence of heart failure symptom, diagnosis and treatment
Measured: 5 years
Secondary outcomes (1)
Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality
Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start30 Jan 2018
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pacemaker ComplicationStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chungnam National University Hospital, Chungbuk National University Hospital, Dankook University, Chung-Ang University Hospital
- Responsible party
- Principal investigator, Ki-Woon Kang, MD, Chung-Ang University Hospital
- Investigators
- KI-Woon Kang, MD PhD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475498
- Sponsor's protocol ID
- EMC 2018-01-013
- Status last verified
- May 2025
- First submitted
- 18 Mar 2018
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Kang KW, Chin JY, Kim TS, Park JH, Choi YJ. Major determinant of the occurrence of pacing-induced cardiomyopathy in complete atrioventricular block: a multicentre, retrospective analysis over a 15-year period in South Korea. BMJ Open. 2018 Feb 8;8(2):e019048. doi: 10.1136/bmjopen-2017-019048.
PubMed 29439074Chin JY, Kang KW, Park SH, Choi YJ, Jung KT, Lee S, Youn HJ. Pre-implant global longitudinal strain as an early sign of pacing-induced cardiomyopathy in patients with complete atrioventricular block. Echocardiography. 2021 Feb;38(2):175-182. doi: 10.1111/echo.14942. Epub 2021 Jan 6.
PubMed 33406280
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT03475498
- Acronym / sponsor ID
- EMC 2018-01-013
- Conditions
- Pacemaker Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Collaborators
- Chungnam National University Hospital, Chungbuk National University Hospital, Dankook University, Chung-Ang University Hospital
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 23 Mar 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.
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.
Detailed description
Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll at least 1000 device patients from multi-centers in order to identify and assess a determinant of PICM and its clinical outcomes (PICM syndrome)
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Being pregnant or plan to become pregnant
- Advanced heart failure waiting in heart transplantation
- Have a life expectancy of less than 1 year
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
Heart failure diagnosis and treatment
Time frame: 5 years
Occurrence of heart failure symptom, diagnosis and treatment
1 secondary outcome
Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 29439074Kim JH, Kang KW, Chin JY, Kim TS, Park JH, Choi YJ. Major determinant of the occurrence of pacing-induced cardiomyopathy in complete atrioventricular block: a multicentre, retrospective analysis over a 15-year period in South Korea. BMJ Open. 2018 Feb 8;8(2):e019048. doi: 10.1136/bmjopen-2017-019048.
- Background: PubMed 33406280Chin JY, Kang KW, Park SH, Choi YJ, Jung KT, Lee S, Youn HJ. Pre-implant global longitudinal strain as an early sign of pacing-induced cardiomyopathy in patients with complete atrioventricular block. Echocardiography. 2021 Feb;38(2):175-182. doi: 10.1111/echo.14942. Epub 2021 Jan 6.
- 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.
Hyu Ryung Cho contact
KI-Woon Kang, MD PhD principal investigator
Chung-Ang University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Complication, run by Eulji University Hospital at 3 sites 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 0 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ki-Woon Kang, MD., PhD. (81 10 4492 2136, kwkang0115@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure diagnosis and treatment (time frame: 5 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 NCT03475498, which also lists 2 linked publications.
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 2 Oct 2025.