HypertensionPhase 4NCT00256152
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
A Phase 4 study testing AF Suppression Pacing Algorithm in people with Hypertension and Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Canada.
Trial summary
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Atrial Fibrillation
- What is being tested?
- AF Suppression Pacing Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,580 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Jun 2010
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
- Recent (< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities.
- In pacemaker patients only the primary indication for pacing is sinus or AV node disease.
Who cannot join
- Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
- Geographic/social or psychiatric factor likely to interfere with follow-up
- Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.
- Conditions
- Hypertension, Atrial Fibrillation
- Being tested
- AF Suppression Pacing Algorithm
- Keywords
- Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF Suppression Pacing AlgorithmDevice
| Study group | Role | What they receive |
|---|---|---|
| AF Suppression OFF | No intervention | Not described |
| AF Suppression ON | Experimental | Not described Receives: Device: AF Suppression Pacing Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of ischemic stroke & Non-CNS systemic embolism
Measured: 3 years
Symptomatic or Asymptomatic AT documented by ECG
Measured: 3 years
Secondary outcomes (1)
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Stuart Connolly, MD, Study chair, McMaster UniversityStephan Hohnloser, MD, Study chair, Goethe UniversityCarlos Morillo, MD, Principal investigator, McMaster UniversityJeff Healey, MD, Principal investigator, McMaster UniversityCarsten Israel, MD, Principal investigator, Goethe UniversityMichael Gold, MD, Principal investigator, Medical University of South CarolinaChu-Pak Lau, MD, Principal investigator, The University of Hong KongAlessandro Capucci, MD, Principal investigator, Ospedale Clinic, Piacenza Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256152
- Sponsor's protocol ID
- CRD291
- Status last verified
- Feb 2019
- First submitted
- 10 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
Publications
Benz AP, Wang J, McIntyre WF, Wong JA, Crystal E, Shurrab M, Israel CW, Hohnloser SH, Gold MR, Connolly SJ, Healey JS. Active-Fixation Atrial Leads and the Risk of Atrial Fibrillation: Insights From ASSERT. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008655. doi: 10.1161/CIRCEP.120.008655. Epub 2020 Jul 23. No abstract available.
PubMed 32701364Perera KS, Sharma M, Connolly SJ, Wang J, Gold MR, Hohnloser SH, Lau CP, Van Gelder IC, Morillo C, Capucci A, Israel CW, Botto G, Healey JS. Stroke type and severity in patients with subclinical atrial fibrillation: An analysis from the Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT). Am Heart J. 2018 Jul;201:160-163. doi: 10.1016/j.ahj.2018.03.027. Epub 2018 Apr 18.
PubMed 29764671Brambatti M, Connolly SJ, Gold MR, Morillo CA, Capucci A, Muto C, Lau CP, Van Gelder IC, Hohnloser SH, Carlson M, Fain E, Nakamya J, Mairesse GH, Halytska M, Deng WQ, Israel CW, Healey JS; ASSERT Investigators. Temporal relationship between subclinical atrial fibrillation and embolic events. Circulation. 2014 May 27;129(21):2094-9. doi: 10.1161/CIRCULATIONAHA.113.007825. Epub 2014 Mar 14.
PubMed 24633881Lau CP, Gbadebo TD, Connolly SJ, Van Gelder IC, Capucci A, Gold MR, Israel CW, Morillo CA, Siu CW, Abe H, Carlson M, Tse HF, Hohnloser SH, Healey JS; ASSERT investigators. Ethnic differences in atrial fibrillation identified using implanted cardiac devices. J Cardiovasc Electrophysiol. 2013 Apr;24(4):381-7. doi: 10.1111/jce.12066. Epub 2013 Jan 28.
PubMed 23356818Hohnloser SH, Healey JS, Gold MR, Israel CW, Yang S, van Gelder I, Capucci A, Lau CP, Fain E, Morillo CA, Ha A, Carlson M, Connolly SJ; ASSERT Investigators. Atrial overdrive pacing to prevent atrial fibrillation: insights from ASSERT. Heart Rhythm. 2012 Oct;9(10):1667-73. doi: 10.1016/j.hrthm.2012.06.012. Epub 2012 Jun 12.
PubMed 22698765Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
PubMed 22236222
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
- ClinicalTrials.gov ID
- NCT00256152
- Acronym / sponsor ID
- CRD291
- Conditions
- Hypertension, Atrial Fibrillation
- Keywords
- Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,580 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Population Health Research Institute
- Study start
- Sep 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Nov 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.
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Suppression OFF | No intervention | – |
| AF Suppression ON | Experimental | Device: AF Suppression Pacing Algorithm |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
- Recent (< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities.
- In pacemaker patients only the primary indication for pacing is sinus or AV node disease.
Key exclusion criteria (3 listed)
- Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
- Geographic/social or psychiatric factor likely to interfere with follow-up
- Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)
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 |
|---|---|---|
| AF Suppression Pacing Algorithm | Device | AF Suppression ON |
Primary outcome
Composite of ischemic stroke & Non-CNS systemic embolism
Time frame: 3 years
Symptomatic or Asymptomatic AT documented by ECG
Time frame: 3 years
1 secondary outcome
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Time frame: 3 years
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 4 Feb 2019.
- Derived from this study: PubMed 32701364Benz AP, Wang J, McIntyre WF, Wong JA, Crystal E, Shurrab M, Israel CW, Hohnloser SH, Gold MR, Connolly SJ, Healey JS. Active-Fixation Atrial Leads and the Risk of Atrial Fibrillation: Insights From ASSERT. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008655. doi: 10.1161/CIRCEP.120.008655. Epub 2020 Jul 23. No abstract available.
- Derived from this study: PubMed 29764671Perera KS, Sharma M, Connolly SJ, Wang J, Gold MR, Hohnloser SH, Lau CP, Van Gelder IC, Morillo C, Capucci A, Israel CW, Botto G, Healey JS. Stroke type and severity in patients with subclinical atrial fibrillation: An analysis from the Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT). Am Heart J. 2018 Jul;201:160-163. doi: 10.1016/j.ahj.2018.03.027. Epub 2018 Apr 18.
- Derived from this study: PubMed 24633881Brambatti M, Connolly SJ, Gold MR, Morillo CA, Capucci A, Muto C, Lau CP, Van Gelder IC, Hohnloser SH, Carlson M, Fain E, Nakamya J, Mairesse GH, Halytska M, Deng WQ, Israel CW, Healey JS; ASSERT Investigators. Temporal relationship between subclinical atrial fibrillation and embolic events. Circulation. 2014 May 27;129(21):2094-9. doi: 10.1161/CIRCULATIONAHA.113.007825. Epub 2014 Mar 14.
- Derived from this study: PubMed 23356818Lau CP, Gbadebo TD, Connolly SJ, Van Gelder IC, Capucci A, Gold MR, Israel CW, Morillo CA, Siu CW, Abe H, Carlson M, Tse HF, Hohnloser SH, Healey JS; ASSERT investigators. Ethnic differences in atrial fibrillation identified using implanted cardiac devices. J Cardiovasc Electrophysiol. 2013 Apr;24(4):381-7. doi: 10.1111/jce.12066. Epub 2013 Jan 28.
- Derived from this study: PubMed 22698765Hohnloser SH, Healey JS, Gold MR, Israel CW, Yang S, van Gelder I, Capucci A, Lau CP, Fain E, Morillo CA, Ha A, Carlson M, Connolly SJ; ASSERT Investigators. Atrial overdrive pacing to prevent atrial fibrillation: insights from ASSERT. Heart Rhythm. 2012 Oct;9(10):1667-73. doi: 10.1016/j.hrthm.2012.06.012. Epub 2012 Jun 12.
- Derived from this study: PubMed 22236222Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
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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.
Stuart Connolly, MD study chair
McMaster University
Stephan Hohnloser, MD study chair
Goethe University
Carlos Morillo, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AF Suppression Pacing Algorithm in people with Hypertension and Atrial Fibrillation, run by Abbott Medical Devices 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 4 inclusion and 3 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 4 Feb 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Composite of ischemic stroke & Non-CNS systemic embolism (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT00256152, which also lists 6 linked publications.
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 4 Feb 2019.