Pacemaker DependencePhase 3NCT00182416
Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
A Phase 3 study testing pacemaker in people with Pacemaker Dependence, run by Hamilton Health Sciences Corporation at 5 sites in Canada.
Trial summary
Pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual chamber pacing, has numerous advantages of low complication rates, lower cost, better longevity, with non-inferiority in the quality of life and hard… Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Pacemaker Dependence
- What is being tested?
- pacemaker
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 5 sitesCanada
- Study dates
- May 2004to Jan 2006
- Phase
- Phase 3
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient has symptomatic bradycardia and is a candidate for first pacemaker implantation
- Patient has high risk of being pacemaker dependent by (at least one of the following):
- Average heart rate of 60 or less on pre-implant Holter
- Maximal heart rate of 60 in patient on telemetry monitoring 12 hrs preoperatively, when not under medications decreasing heart rate, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed
- First degree AV block with PR intervals > 300 ms, or second degree AV block at heart rates <= 80 bpm.
- Dependence for 12 hrs when on temporary pacemaker set at 50 bpm if bradycardia is not secondary to medication, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed.
Who cannot join
- Age <= 65 years
- Chronic Atrial Fibrillation
- Indication for ICD
- Non-cardiovascular death is likely to occur within 3 years
- Geographical, social, or psychiatric reasons making follow-up problematic
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton Health Sciences - General Division
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, N2M 1B2
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual chamber pacing, has numerous advantages of low complication rates, lower cost, better longevity, with non-inferiority in the quality of life and hard outcomes proven in direct randomized comparisons. However, comparison between single and dual chamber pacers was never adequate, since not more then half of the patients in the trials were actually using pacemakers for the majority of the time. Routine dual chamber pacing using a right ventricle apical lead is also associated with significant increase in peri-operative and remote complications. Some of these complications may be related to ventricular desynchronization secondary to the pacing location, which is potentially avoidable by using biventricular pacing. A randomized trial which will compare single chamber rate responsive pacing to the best available modification of dual chamber pacing (biventricular pacing) in suitable patients is therefore warranted.
- Conditions
- Pacemaker Dependence
- Being tested
- pacemaker
- Keywords
- pacemakers, atrial fibrillation, stroke, cardiovascular death
- 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.
pacemakerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of future pacemaker dependence
Feasibility of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DependenceStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Sunnybrook Health Sciences Centre
- Investigators
- Eugene Crystal, MD, Study chair, Sunnybrook & Women's College Health Sciences CentreRobin S Roberts, Principal investigator, McMaster Univeristy, Department of Clinical Epidemiology & BiostatisticsStuart Connolly, MD, Principal investigator, Hamilton Health Sciences - General DivisionPaul Dorian, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182416
- Sponsor's protocol ID
- CTMG-2005-CTOPPII
- Status last verified
- Oct 2007
- First submitted
- 13 Sep 2005
- Last updated
- 19 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
- ClinicalTrials.gov ID
- NCT00182416
- Acronym / sponsor ID
- CTMG-2005-CTOPPII
- Conditions
- Pacemaker Dependence
- Keywords
- pacemakers, atrial fibrillation, stroke, cardiovascular death
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Medtronic, Sunnybrook Health Sciences Centre
- Study start
- May 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Sep 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.
Pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular (AV) node dysfunction. Single chamber pacing when compared with dual chamber pacing, has numerous advantages of low complication rates, lower cost, better longevity, with non-inferiority in the quality of life and hard outcomes proven in direct randomized comparisons. However, comparison between single and dual chamber pacers was never adequate, since not more then half of the patients in the trials were actually using pacemakers for the majority of the time. Routine dual chamber pacing using a right ventricle apical lead is also associated with significant increase in peri-operative and remote complications. Some of these complications may be related to ventricular desynchronization secondary to the pacing location, which is potentially avoidable by using biventricular pacing. A randomized trial which will compare single chamber rate responsive pacing to the best available modification of dual chamber pacing (biventricular pacing) in suitable patients is therefore warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patient has symptomatic bradycardia and is a candidate for first pacemaker implantation
- Patient has high risk of being pacemaker dependent by (at least one of the following):
Key exclusion criteria (5 listed)
- Age <= 65 years
- Chronic Atrial Fibrillation
- Indication for ICD
- Non-cardiovascular death is likely to occur within 3 years
- Geographical, social, or psychiatric reasons making follow-up problematic
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
Predictors of future pacemaker dependence
Feasibility of the trial
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 19 Oct 2007.
Related trials for Pacemaker Dependence
Recruiting
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
Atrial Fibrillation (AF), Pacemaker Therapy
RecruitingObservational study
One Year Pacing Dependency After TAVR
Patients Above 18 Years, Patient Discharge
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.
Eugene Crystal, MD study chair
Sunnybrook & Women's College Health Sciences Centre
Robin S Roberts principal investigator
McMaster Univeristy, Department of Clinical Epidemiology & Biostatistics
Stuart Connolly, MD principal investigator
Hamilton Health Sciences - General Division
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pacemaker in people with Pacemaker Dependence, run by Hamilton Health Sciences Corporation at 5 sites 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 6 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: finished, as of the sponsor's last update on 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Predictors of future pacemaker dependence. The study lists 2 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 19 Oct 2007.