Post Pacemaker Implantation PatientsNCT03303872
Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
An observational study of Post Pacemaker Implantation Patients, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Pacemaker Implantation Patients
- How many people
- 900 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2017to 31 Dec 2022
- How long will I take part?
- 3 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients post pacemaker implantation
Who may be able to join
- Age: 18-80 years
- Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
- Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
- Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
- Patients who are willing to sign the informed consent.
- Patients who are willing to receive the implantation and post-operative follow-up.
Who cannot join
- Persistent or permanent AF
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
- Thyroid gland dysfunction
- Pregnancy
- Malignant tumor
- Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- Life expectancy < 12 months
- Patients unable or unwilling to cooperate in the study procedures.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Boyoung Joung, M.D., Ph.D., 82-10-8025-0424, CBY690@yuhs.ac
About this study
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.
- Conditions
- Post Pacemaker Implantation Patients
- Keywords
- atrial high rate episode, pacemaker, atrial fibrillation, stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF-pacemaker registry | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Measured: 3 months after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Measured: 6 months after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant
Measured: every 1 year upto 3 years after pacemaker implantation
Occurrence of stroke
Stroke based on device detected subclinical atrial fibrillation episodes
Measured: 3 months after pacemaker implantation
Occurrence of stroke
Stroke based on device detected subclinical atrial fibrillation episodes
Measured: 6 months after pacemaker implantation
Occurrence of stroke
Stroke based on device detected subclinical atrial fibrillation episodes
Measured: every 1 year upto 3 years after pacemaker implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start31 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Post Pacemaker Implantation PatientsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303872
- Sponsor's protocol ID
- 1-2017-0008
- Status last verified
- Jun 2018
- First submitted
- 17 Sep 2017
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim M, Kim TH, Yu HT, Choi EK, Park HS, Park J, Lee YS, Kang KW, Shim J, Sung JH, Oh IY, Joung B; AF-Pacemaker Study Group. Prevalence and Predictors of Clinically Relevant Atrial High-Rate Episodes in Patients with Cardiac Implantable Electronic Devices. Korean Circ J. 2021 Mar;51(3):235-247. doi: 10.4070/kcj.2020.0393.
PubMed 33655723
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
- ClinicalTrials.gov ID
- NCT03303872
- Acronym / sponsor ID
- 1-2017-0008
- Conditions
- Post Pacemaker Implantation Patients
- Keywords
- atrial high rate episode, pacemaker, atrial fibrillation, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Oct 2017 (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 is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF-pacemaker registry | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients post pacemaker implantation
Key inclusion criteria (6 listed)
- Age: 18-80 years
- Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
- Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
- Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
- Patients who are willing to sign the informed consent.
Key exclusion criteria (8 listed)
- Persistent or permanent AF
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
- Thyroid gland dysfunction
- Pregnancy
- Malignant tumor
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
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Time frame: 3 months after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Time frame: 6 months after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
Time frame: every 1 year upto 3 years after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant
Occurrence of stroke
Time frame: 3 months after pacemaker implantation
Stroke based on device detected subclinical atrial fibrillation episodes
Occurrence of stroke
Time frame: 6 months after pacemaker implantation
Stroke based on device detected subclinical atrial fibrillation episodes
Occurrence of stroke
Time frame: every 1 year upto 3 years after pacemaker implantation
Stroke based on device detected subclinical atrial fibrillation episodes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 33655723Kim M, Kim TH, Yu HT, Choi EK, Park HS, Park J, Lee YS, Kang KW, Shim J, Sung JH, Oh IY, Joung B; AF-Pacemaker Study Group. Prevalence and Predictors of Clinically Relevant Atrial High-Rate Episodes in Patients with Cardiac Implantable Electronic Devices. Korean Circ J. 2021 Mar;51(3):235-247. doi: 10.4070/kcj.2020.0393.
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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.
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 Post Pacemaker Implantation Patients, run by Yonsei University 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 6 inclusion and 8 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 20 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 Boyoung Joung, M.D., Ph.D. (82-10-8025-0424, CBY6908@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of subclinical atrial fibrillation (atrial high rate episode) (time frame: 3 months after pacemaker implantation). The study lists 6 primary outcomes in all. 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 NCT03303872, 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 20 Jun 2018.