Atrioventricular BlockNCT03024047
Cohort Description of Younger With AV-block
An observational study of Atrioventricular Block and Progressive Cardiac Conduction Defect, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be lifesaving. Read more about this study
- Who is it for?
- Ages Up to 49 years
- Conditions the study is for
- Atrioventricular Block, Progressive Cardiac Conduction Defect, Genetic Disease
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- How many people
- 1,255 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Aug 2018
- 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 Up to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients in Denmark with AV-block who were treated with pacemaker for the first time between 01.01.1996 - 31.12.2015 with age at implantation <50 years will be included in the study (n=1,255 patients).
Who may be able to join
- All patients in Denmark
- Treated with pacemaker due to AV-block
- Implanted for the first time between 01.01.1996 - 31.12.2015
- Age at implantation <50 years
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of cardiology, Research, Aarhus University Hospital, Denmark
Aarhus, 8200
Johnni T. R. Dideriksen, M.D., 0045 40832508, johndide@rm.dk
About this study
Background:
Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be lifesaving.
Read more
AV-block in younger can be seen along with structural or ischemic heart disease, congenital heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases, sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in conditions, primarily localized to the AV-node without other cardiac disease at diagnosis.
This form of AV-block is often hereditary and can be seen in families where relatives have another types of heart disease in form of fore example, cardiomyopathy, ion channel disease or sudden death. The different forms of presentation are due to the same gene mutation being expressed differently within the same family. Thus, early onset of AV-block (<50 years) may indicate hereditary AV-conduction disorder but it can also be the first manifestation of severe ion channel disease or cardiomyopathy.
Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced AV-block. There have been no overall figures regarding the causes of advanced AV-block, and therefore no systematic approach to diagnosing this group of patients. Furthermore, the prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often overlooked diagnosis among younger patients with advanced AV-blok. There are no data on disease progression after diagnosis, and therefore there is no evidence-based knowledge about how these patients should be followed after diagnosis.
With modern gene technology, a range of new, yet unknown genes with potentially pathogenic mutations is likely to be identified. Identification of such genes, and the development of a strategy for systematic approach to diagnose younger patients with AV-block, will enable presymptomatic genetic screening of relatives and implementation of evidence-based, preventive treatment with pacemaker and/or medical treatment for heart failure based on a specific genetic predisposition for development of AV-block with or without heart failure.
Hypotheses:
In a significant proportion of younger patients with advanced AV-block the underlying cause is unknown.
Objective:
To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark and describe the current diagnostics.
Method:
The study is a cross sectional study. The patients for this study are identified from Danish Pacemaker and ICD Register. The investigators will review medical records and obtain clinical information and test results (see detailed description).
Perspectives:
This study is the first part of a large study of AV-block in younger patients in Denmark. The overall goal, is to increase knowledge about the causes of and disease progression after the diagnosis of advanced AV-block in young patients which could lead to a significant improvement in the treatment of this patient group and may lead to a customized choice of pacemaker type in the future and perhaps additional medical treatment in this patient group. This could potentially lead to a reduction in both their morbidity mortality.
Read the detailed description
Method:
The following covariates will be reported.
Date of diagnosis of AV-block:
The date of diagnosis is defined as the day the physician diagnoses the AV-block. E.g. if the patient has a Holter monitoring performed, the date of diagnosis is the dag the monitoring is reviewed.
Reported as: Day-month-year
Comorbidity at day of first pacemaker implant:
Registered as one or more of the following:
- Diabetes
- Hypertension
- Hypercholesterolemia
- Heart failure
- Atrial fibrillation or flutter
- Ischemic heart disease
- Sarcoidosis
- Connecting tissue disorder
- Other
Smoking status at day of first pacemaker implant:
Registered as: Current, former, never
Device selected at first pacemaker implant:
Registered as: DDD, CTR, etcetera
Genetic investigation:
Is there performed genetic investigation due to the finding of AV-block? Investigation must be initiated maximum 4 weeks after day of first pacemaker implant.
Registered as: y/n.
Date of first pacemaker implant:
Registered as: Day-month-year
Implant sight
ECG 12 description:
ECG 12 must be taken maximum one week before day of first pacemaker implant Registered as: Bpm., RBBB y/n, LBBB y/n, PR in msec, QRS in msec, QT in msec, QTc in msec (Frederica)
Implant indication:
Registered as one of following:
- First-degree atrioventricular block with symptoms
- Mobitz type 1 with symptoms
- Mobitz type 2
- Advanced second-degree atrioventricular block
- Third-degree atrioventricular block
- Unknown The most malignant is chosen and it is reported if it is intermittent or persistent.
Symptoms:
Registered as one or more of following:
- Dyspnoea
- Fatigue
- Malaise
- Dizziness
- Syncope
- Angina
- Cardiac arrest
- No symptoms
Echocardiography:
Performed maximum two weeks before day of first pacemaker implant The reported values are what the echocardiographer describes.
Registered as:
LVEF in % (values over 60% is reported as >60 %) Hypertrophy of LV y/n Dilatation of LV y/n Dilatation of LA y/n Valvular disease/artificial valve y/n
Coronary angiography:
At day of first pacemaker implant +/- 4 weeks
Registered as:
Normal y/n Significantly disease on LAD y/n Significantly disease on RCA y/n Significantly disease on CX y/n Significantly disease = leading to CABG, PCI or antithrombotic treatment
- Being tested
- Pacemaker
- Medical subject headings
- Atrioventricular Block, Bundle-Branch Block, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of structural heart disease as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of ischemic heart disease as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of congenital heart disease as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of congenital AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of muscular dystrophy as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of sarcoidosis as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of lyme disease as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of genetic cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of complications to operation as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of complications to radio frequency ablation as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of endocarditis as cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Prevalence of unknown cause of AV-block
Measured: 01.01.1996 - 31.12.2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Time perspective
- Retrospective
- Enrolment
- 1,255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024047
- Sponsor's protocol ID
- DAN-BLOCK_Study1
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Description of Younger With AV-block
- ClinicalTrials.gov ID
- NCT03024047
- Acronym / sponsor ID
- DAN-BLOCK_Study1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,255 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Aug 2018 (estimated)
- First posted
- 18 Jan 2017 (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.
Background:
Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be lifesaving.
AV-block in younger can be seen along with structural or ischemic heart disease, congenital heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases, sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in conditions, primarily localized to the AV-node without other cardiac disease at diagnosis.
This form of AV-block is often hereditary and can be seen in families where relatives have another types of heart disease in form of fore example, cardiomyopathy, ion channel disease or sudden death. The different forms of presentation are due to the same gene mutation being expressed differently within the same family. Thus, early onset of AV-block (<50 years) may indicate hereditary AV-conduction disorder but it can also be the first manifestation of severe ion channel disease or cardiomyopathy.
Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced AV-block. There have been no overall figures regarding the causes of advanced AV-block, and therefore no systematic approach to diagnosing this group of patients. Furthermore, the prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often overlooked diagnosis among younger patients with advanced AV-blok. There are no data on disease progression after diagnosis, and therefore there is no evidence-based knowledge about how these patients should be followed after diagnosis.
With modern gene technology, a range of new, yet unknown genes with potentially pathogenic mutations is likely to be identified. Identification of such genes, and the development of a strategy for systematic approach to diagnose younger patients with AV-block, will enable presymptomatic genetic screening of relatives and implementation of evidence-based, preventive treatment with pacemaker and/or medical treatment for heart failure based on a specific genetic predisposition for development of AV-block with or without heart failure.
Hypotheses:
In a significant proportion of younger patients with advanced AV-block the underlying cause is unknown.
Objective:
To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark and describe the current diagnostics.
Method:
The study is a cross sectional study. The patients for this study are identified from Danish Pacemaker and ICD Register. The investigators will review medical records and obtain clinical information and test results (see detailed description).
Perspectives:
This study is the first part of a large study of AV-block in younger patients in Denmark. The overall goal, is to increase knowledge about the causes of and disease progression after the diagnosis of advanced AV-block in young patients which could lead to a significant improvement in the treatment of this patient group and may lead to a customized choice of pacemaker type in the future and perhaps additional medical treatment in this patient group. This could potentially lead to a reduction in both their morbidity mortality.
Detailed description
Method:
The following covariates will be reported.
Date of diagnosis of AV-block:
The date of diagnosis is defined as the day the physician diagnoses the AV-block. E.g. if the patient has a Holter monitoring performed, the date of diagnosis is the dag the monitoring is reviewed.
Reported as: Day-month-year
Comorbidity at day of first pacemaker implant:
Registered as one or more of the following:
- Diabetes
- Hypertension
- Hypercholesterolemia
- Heart failure
- Atrial fibrillation or flutter
- Ischemic heart disease
- Sarcoidosis
- Connecting tissue disorder
- Other
Smoking status at day of first pacemaker implant:
Registered as: Current, former, never
Device selected at first pacemaker implant:
Registered as: DDD, CTR, etcetera
Genetic investigation:
Is there performed genetic investigation due to the finding of AV-block? Investigation must be initiated maximum 4 weeks after day of first pacemaker implant.
Registered as: y/n.
Date of first pacemaker implant:
Registered as: Day-month-year
Implant sight
ECG 12 description:
ECG 12 must be taken maximum one week before day of first pacemaker implant Registered as: Bpm., RBBB y/n, LBBB y/n, PR in msec, QRS in msec, QT in msec, QTc in msec (Frederica)
Implant indication:
Registered as one of following:
- First-degree atrioventricular block with symptoms
- Mobitz type 1 with symptoms
- Mobitz type 2
- Advanced second-degree atrioventricular block
- Third-degree atrioventricular block
- Unknown The most malignant is chosen and it is reported if it is intermittent or persistent.
Symptoms:
Registered as one or more of following:
- Dyspnoea
- Fatigue
- Malaise
- Dizziness
- Syncope
- Angina
- Cardiac arrest
- No symptoms
Echocardiography:
Performed maximum two weeks before day of first pacemaker implant The reported values are what the echocardiographer describes.
Registered as:
LVEF in % (values over 60% is reported as >60 %) Hypertrophy of LV y/n Dilatation of LV y/n Dilatation of LA y/n Valvular disease/artificial valve y/n
Coronary angiography:
At day of first pacemaker implant +/- 4 weeks
Registered as:
Normal y/n Significantly disease on LAD y/n Significantly disease on RCA y/n Significantly disease on CX y/n Significantly disease = leading to CABG, PCI or antithrombotic treatment
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients in Denmark with AV-block who were treated with pacemaker for the first time between 01.01.1996 - 31.12.2015 with age at implantation <50 years will be included in the study (n=1,255 patients).
Key inclusion criteria (4 listed)
- All patients in Denmark
- Treated with pacemaker due to AV-block
- Implanted for the first time between 01.01.1996 - 31.12.2015
- Age at implantation <50 years
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| Pacemaker | Device | – |
Primary outcome
Prevalence of structural heart disease as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of ischemic heart disease as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of congenital heart disease as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of congenital AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of muscular dystrophy as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of sarcoidosis as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of lyme disease as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of genetic cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of complications to operation as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of complications to radio frequency ablation as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of endocarditis as cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Prevalence of unknown cause of AV-block
Time frame: 01.01.1996 - 31.12.2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Related trials for Atrioventricular Block
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Recruiting
Novel Approach to Conduction System Pacing With Use of Ultrasound
Conduction Block, Atrioventricular, Bundle-Branch Block
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 Atrioventricular Block and Progressive Cardiac Conduction Defect, run by University of Aarhus at 1 site in Denmark.
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 4 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 18 Jan 2017. 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 Denmark. 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 Johnni T. R. Dideriksen, M.D. (0045 40832508, johndide@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of structural heart disease as cause of AV-block (time frame: 01.01.1996 - 31.12.2015). The study lists 12 primary outcomes in all. 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 18 Jan 2017.