Atrial FibrillationNCT00116987
Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older
A study testing Dual chamber cardiac pacemaker and Single chamber cardiac pacemaker in people with Atrial Fibrillation and Cardiac Pacing, Artificial, run by University of Calgary at 1 site in Canada.
Trial summary
Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiac Pacing, Artificial
- What is being tested?
- Dual chamber cardiac pacemaker and Single chamber cardiac pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2003to Nov 2009
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 80 years of age and older
- Symptomatic bradycardia
Who cannot join
- Permanent atrial fibrillation
- Previous pacemaker implant
- Life expectancy less than 1 year
- Geographic isolation
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode.
We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of life.
Read the detailed description
Many patients who are 80 years of age and older, develop AF or CHF. Physiologic pacing has been shown to prevent AF compared to ventricular pacing. Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown.
The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities.
Patients recruited to the study will be randomized to either DDDR or VVIR pacing, and followed in the clinic every 6 months for the 3 years of the study.
- Conditions
- Atrial Fibrillation, Cardiac Pacing, Artificial
- Being tested
- Dual chamber cardiac pacemaker, Single chamber cardiac pacemaker
- Keywords
- physiologic pacing, ventricular pacing, hospitalizations
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual chamber cardiac pacemakerDevice
Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
Single chamber cardiac pacemakerDevice
Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. Receives: Device: Dual chamber cardiac pacemaker |
| 2 | Other | Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. Receives: Device: Single chamber cardiac pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
Measured: approximately 3 - 5 years
Secondary outcomes (1)
To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life
Measured: approximately 3 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startAug 2003
- Primary completionSep 2008
- Study completionNov 2009
Why it stopped: Unable to recruit adequate number of participants in required time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Health Trust
- Responsible party
- Principal investigator, Dr. Anne M. Gillis, University of Calgary
- Investigators
- Anne M Gillis, MD, Principal investigator, Director of Pacing and Electrophysiology, Professor of Medicine, University of CalgaryDerek V Exner, MD, MPH, Study director, University of CalgaryD. George Wyse, MD, PhD, Study director, University of CalgaryL. Brent Mitchell, MD, Study director, University of CalgaryRobert S Sheldon, MD, Ph D, Study director, University of CalgaryJohn M Rothschild, MD, Study director, University of CalgaryHenry J Duff, MD, Study director, University of CalgaryJohn Burgess, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116987
- Sponsor's protocol ID
- 17096
- Status last verified
- Jun 2015
- First submitted
- 30 Jun 2005
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing the Octogenarian Plus Population (POPP) A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older
- ClinicalTrials.gov ID
- NCT00116987
- Acronym / sponsor ID
- 17096
- Conditions
- Atrial Fibrillation, Cardiac Pacing, Artificial
- Keywords
- physiologic pacing, ventricular pacing, hospitalizations
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit adequate number of participants in required time frame.
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Calgary Health Trust
- Study start
- Aug 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Jul 2005 (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.
Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode.
We wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (CHF), atrial fibrillation (AF)) resulting in improved quality of life.
Detailed description
Many patients who are 80 years of age and older, develop AF or CHF. Physiologic pacing has been shown to prevent AF compared to ventricular pacing. Whether prevention of AF and CHF by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown.
The investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities.
Patients recruited to the study will be randomized to either DDDR or VVIR pacing, and followed in the clinic every 6 months for the 3 years of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Dual chamber cardiac pacemakerPhysiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. |
| 2 | Other | Device: Single chamber cardiac pacemakerVentricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 80 years of age and older
- Symptomatic bradycardia
Key exclusion criteria (5 listed)
- Permanent atrial fibrillation
- Previous pacemaker implant
- Life expectancy less than 1 year
- Geographic isolation
- Unable to give informed consent
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 |
|---|---|---|
| Dual chamber cardiac pacemakerPhysiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle. | Device | 1 |
| Single chamber cardiac pacemakerVentricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle. | Device | 2 |
Primary outcome
To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes
Time frame: approximately 3 - 5 years
1 secondary outcome
To determine which pacing mode, physiologic or ventricular, is associated with improved functional capacity and improved quality of life
Time frame: approximately 3 - 5 years
Results and safety
The study was stopped early (reason given: Unable to recruit adequate number of participants in required time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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.
Anne M Gillis, MD principal investigator
Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary
Derek V Exner, MD, MPH study director
University of Calgary
D. George Wyse, MD, PhD study director
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual chamber cardiac pacemaker and Single chamber cardiac pacemaker in people with Atrial Fibrillation and Cardiac Pacing, Artificial, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Jun 2015. 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 Canada. 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 was stopped early (reason given: Unable to recruit adequate number of participants in required time frame.). Results are not available in the source record.
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?
To determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular/cerebrovascular causes (time frame: approximately 3 - 5 years). 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 15 Jun 2015.