Sick Sinus SyndromePhase 3NCT02317068
Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
A Phase 3 study testing HBR and DD in people with Sick Sinus Syndrome and Paroxysmal Atrial Fibrillation, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial summary
This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
- What is being tested?
- HBR and DD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sick sinus syndrome patients having dual-chamber pacemaker
- Having paroxysmal AF defined as at least 2 episodes of AHR/AMS >190 b/min lasting >6 minutes
- Having normal atrioventricular conduction
Who cannot join
- Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)
- History of acute coronary syndrome
- Significant heart valve disease
- Chronic AF before randomization
- Overt heart failure
- Malignancy
- Any reasons for antiarrhythmic medication use
- Inability to follow patients every 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.
- Being tested
- HBR, DD
- Keywords
- sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBRDevice
Also called High Atrial Base Rate Pacing
DDDevice
Also called Device Default
| Study group | Role | What they receive |
|---|---|---|
| High Atrial Base Rate Pacing | Experimental | The base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch Receives: Device: HBR |
| Device Default | Active comparator | The base rate of pacemaker will be determined 60 beats/minute Receives: Device: DD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial high rate/Automatic mode switch episodes
The number of AHR/AMS episodes recorded by pacemaker
Measured: During 6 Months
Secondary outcomes (5)
Stroke
The development of stroke during follow-up
Measured: During 6 months
Myocardial infarction
The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation
Measured: During 6 months
Heart failure
The development or progression of heart failure during follow-up
Measured: During 6 months
Worsening Functional Class
The worsening of functional class
Measured: During 6 months
Death
Death
Measured: During 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chancellor of research, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317068
- Sponsor's protocol ID
- UMSU-Cardiology-4
- Status last verified
- Oct 2015
- First submitted
- 10 Dec 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02317068
- Acronym / sponsor ID
- UMSU-Cardiology-4
- Keywords
- sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Dec 2014 (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.
This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Atrial Base Rate Pacing | Experimental | Device: HBRThe base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch |
| Device Default | Active comparator | Device: DDThe base rate of pacemaker will be determined 60 beats/minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sick sinus syndrome patients having dual-chamber pacemaker
- Having paroxysmal AF defined as at least 2 episodes of AHR/AMS >190 b/min lasting >6 minutes
- Having normal atrioventricular conduction
Key exclusion criteria (8 listed)
- Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)
- History of acute coronary syndrome
- Significant heart valve disease
- Chronic AF before randomization
- Overt heart failure
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 |
|---|---|---|
| HBRAlso: High Atrial Base Rate Pacing | Device | High Atrial Base Rate Pacing |
| DDAlso: Device Default | Device | Device Default |
Primary outcome
Atrial high rate/Automatic mode switch episodes
Time frame: During 6 Months
The number of AHR/AMS episodes recorded by pacemaker
5 secondary outcomes
Stroke
Time frame: During 6 months
Myocardial infarction
Time frame: During 6 months
Heart failure
Time frame: During 6 months
Worsening Functional Class
Time frame: During 6 months
Death
Time frame: During 6 months
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 21 Oct 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.
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?
A Phase 3 study testing HBR and DD in people with Sick Sinus Syndrome and Paroxysmal Atrial Fibrillation, run by Urmia University of Medical Sciences at 1 site in Iran.
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 3 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: finished, as of the sponsor's last update on 21 Oct 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 Iran. 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?
Atrial high rate/Automatic mode switch episodes (time frame: During 6 Months). 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 21 Oct 2015.