Pacemaker DDDNCT04269733
Risk of Pacing-induced Cardiomyopathy
An observational study of Pacemaker DDD and Atrioventricular Block, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pacemaker DDD, Atrioventricular Block, Pacing-Induced Cardiomyopathy
- What is being tested?
- Right ventricular pacing
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 1 Aug 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a normal or near-normal ejection fraction prior to pacemaker implantation who received a DDD-pacemaker due to high-degree AV block ≥ 1 years prior to screening.
Who may be able to join
- Male or female ≥ 18 years
- De novo DDD PM implanted at Aalborg University Hospital
- PM implantation due to advanced AV block
- Duration of pacemaker treatment ≥ 1 year at time of screening
- Normal LVEF (≥50%) prior to PM implantation
- Actively attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
Who cannot join
- No written informed consent
- Baseline TTE not available or insufficient quality for assessment of LVEF
- Contraindications to a new contrast CT if no previous contrast-enhanced cardiac CT, showing RV lead position, is available
- RV pacing load < 40%.
- Deceased
- Not attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
Show all 9Show fewer
- Device complications with removal of original implanted pacing lead > 3 months after primary implantation
- Subjects with severe ischemic heart disease and severe valvular heart disease.
- Terminal illness or unable to provide informed consent at time of screening
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Pacing-induced Cardiomyopathy - the Importance of Right Ventricular Pacing Site and Patterns of Dyssynchronous Myocardial Activation
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
Read the detailed description
Background:
Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssynchronous electrical and mechanical activation of the myocardium. The activation is affected by the RV pacing site. Understanding the consequences of different RV pacing sites and the patterns of dyssynchrony may help to choose the optimal treatment for the individual patient.
Aim and objectives:
The overall aim of this project is to investigate the association between RV pacing site and the risk of PICM. Contrast enhanced cardiac computed tomography (CT) will be applied for precise localization of the RV pacing. Furthermore, investigation of the association between PICM and different mechanical and electrical myocardial activation patterns during RV pacing will be conducted using new echocardiographic and electrocardiographic methods.
Methods:
The study is designed as a retrospective cohort study with clinical follow-up. Patients with prior pacemaker implantation due to advanced atrioventricular block will be included. The study baseline is retrospective and defined as time of pacemaker implantation and follow-up is time of inclusion. Baseline data will be extracted from the Danish Pacemaker- and ICD Registry, electronic medical records (EMR) and review of echocardiographs. Follow-up data will be extracted from existing data in the EMRs as well as generated during a follow-up visit with a clinical examination. For assessment of cardiac function, RV lead position and electrical and mechanical activations patterns, the examination will include a transthoracic echocardiography, an electrocardiogram, a 3-dimensional chest photo, and a contrast-enhanced cardiac CT. Data will be analysed for differences between those who develop PICM and those who do not.
Expected outcomes and perspectives:
The hope is that this project will generate knowledge and awareness on pacemaker treatment and the risk of PICM. Understanding the pathophysiology behind PICM is key to learning how to prevent it. Accordingly, this project has the potential to contribute to improving pacemaker treatment and the quality of care for the large and still growing PM population.
- Being tested
- Right ventricular pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ventricular pacingDevice
Right ventricular pacing from a DDD pacemaker implanted due to high-degree AV block
| Study group | Role | What they receive |
|---|---|---|
| Subjects with a DDD-pacemaker due to high-degree AV block | Not described Receives: Device: Right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacing-induced cardiomyopathy
Time to development of PICM. PICM is defined as ≥ 10% decrease in LVEF resulting in LVEF < 50% after pacemaker implantation.
Measured: After ≥ 1 years of exposure to right ventricular pacing
Secondary outcomes (5)
Composite endpoint of new-onset heart failure
HF diagnosis and/or HF hospitalization and/or Upgrading from a DDD PM to a CRT system after pacemaker implantation.
Measured: After ≥ 1 year of exposure to right ventricular pacing
Change in LVEF
Change in LVEF after pacemaker implantation.
Measured: After ≥ 1 year of exposure to right ventricular pacing
New-onset atrial fibrillation and/or atrial flutter
New diagnosis of atrial fibrillation and/or atrial flutter after pacemaker implantation.
Measured: After ≥ 1 years of exposure to right ventricular pacing
Change in LV end-diastolic volume
Change in LV end-diastolic volume after pacemaker implantation.
Measured: After ≥ 1 years of exposure to right ventricular pacing
Change in LV end-systolic volume
Change in LV end-systolic volume after pacemaker implantation.
Measured: After ≥ 1 years of exposure to right ventricular pacing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Svend Andersens Foundation, Peacs, Aalborg University, Karl G Andersens Fond, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Patricia Fruelund, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269733
- Sponsor's protocol ID
- 2020-015
- Status last verified
- Aug 2021
- First submitted
- 12 Feb 2020
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing-induced Cardiomyopathy - the Importance of Right Ventricular Pacing Site and Patterns of Dyssynchronous Myocardial Activation
- ClinicalTrials.gov ID
- NCT04269733
- Acronym / sponsor ID
- 2020-015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Svend Andersens Foundation, Peacs, Aalborg University, Karl G Andersens Fond, Sygekassernes Helsefond
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 Feb 2020 (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 will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
Detailed description
Background:
Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssynchronous electrical and mechanical activation of the myocardium. The activation is affected by the RV pacing site. Understanding the consequences of different RV pacing sites and the patterns of dyssynchrony may help to choose the optimal treatment for the individual patient.
Aim and objectives:
The overall aim of this project is to investigate the association between RV pacing site and the risk of PICM. Contrast enhanced cardiac computed tomography (CT) will be applied for precise localization of the RV pacing. Furthermore, investigation of the association between PICM and different mechanical and electrical myocardial activation patterns during RV pacing will be conducted using new echocardiographic and electrocardiographic methods.
Methods:
The study is designed as a retrospective cohort study with clinical follow-up. Patients with prior pacemaker implantation due to advanced atrioventricular block will be included. The study baseline is retrospective and defined as time of pacemaker implantation and follow-up is time of inclusion. Baseline data will be extracted from the Danish Pacemaker- and ICD Registry, electronic medical records (EMR) and review of echocardiographs. Follow-up data will be extracted from existing data in the EMRs as well as generated during a follow-up visit with a clinical examination. For assessment of cardiac function, RV lead position and electrical and mechanical activations patterns, the examination will include a transthoracic echocardiography, an electrocardiogram, a 3-dimensional chest photo, and a contrast-enhanced cardiac CT. Data will be analysed for differences between those who develop PICM and those who do not.
Expected outcomes and perspectives:
The hope is that this project will generate knowledge and awareness on pacemaker treatment and the risk of PICM. Understanding the pathophysiology behind PICM is key to learning how to prevent it. Accordingly, this project has the potential to contribute to improving pacemaker treatment and the quality of care for the large and still growing PM population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with a DDD-pacemaker due to high-degree AV block | – | Device: Right ventricular pacing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a normal or near-normal ejection fraction prior to pacemaker implantation who received a DDD-pacemaker due to high-degree AV block ≥ 1 years prior to screening.
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years
- De novo DDD PM implanted at Aalborg University Hospital
- PM implantation due to advanced AV block
- Duration of pacemaker treatment ≥ 1 year at time of screening
- Normal LVEF (≥50%) prior to PM implantation
Key exclusion criteria (9 listed)
- No written informed consent
- Baseline TTE not available or insufficient quality for assessment of LVEF
- Contraindications to a new contrast CT if no previous contrast-enhanced cardiac CT, showing RV lead position, is available
- RV pacing load < 40%.
- Deceased
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 |
|---|---|---|
| Right ventricular pacingRight ventricular pacing from a DDD pacemaker implanted due to high-degree AV block | Device | Subjects with a DDD-pacemaker due to high-degree AV block |
Primary outcome
Pacing-induced cardiomyopathy
Time frame: After ≥ 1 years of exposure to right ventricular pacing
Time to development of PICM. PICM is defined as ≥ 10% decrease in LVEF resulting in LVEF < 50% after pacemaker implantation.
5 secondary outcomes
Composite endpoint of new-onset heart failure
Time frame: After ≥ 1 year of exposure to right ventricular pacing
Change in LVEF
Time frame: After ≥ 1 year of exposure to right ventricular pacing
New-onset atrial fibrillation and/or atrial flutter
Time frame: After ≥ 1 years of exposure to right ventricular pacing
Change in LV end-diastolic volume
Time frame: After ≥ 1 years of exposure to right ventricular pacing
Change in LV end-systolic volume
Time frame: After ≥ 1 years of exposure to right ventricular pacing
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 12 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pacemaker DDD and Atrioventricular Block, run by Aalborg University Hospital 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 6 inclusion and 9 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 12 Aug 2021. 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?
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?
Pacing-induced cardiomyopathy (time frame: After ≥ 1 years of exposure to right ventricular pacing). 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 12 Aug 2021.