Back to resultsAsymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
Primary Purpose
Hypertension, Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
AF Suppression Pacing Algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.)
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
AF Suppression OFF
AF Suppression ON
Arm Description
Outcomes
Primary Outcome Measures
Composite of ischemic stroke & Non-CNS systemic embolism
Symptomatic or Asymptomatic AT documented by ECG
Secondary Outcome Measures
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Full Information
NCT ID
NCT00256152
First Posted
September 10, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
Collaborators
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00256152
Brief Title
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
Official Title
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Population Health Research Institute
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Atrial Fibrillation
Keywords
Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2580 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF Suppression OFF
Arm Type
No Intervention
Arm Title
AF Suppression ON
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AF Suppression Pacing Algorithm
Primary Outcome Measure Information:
Title
Composite of ischemic stroke & Non-CNS systemic embolism
Time Frame
3 years
Title
Symptomatic or Asymptomatic AT documented by ECG
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Connolly, MD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephan Hohnloser, MD
Organizational Affiliation
Goethe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Morillo, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeff Healey, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carsten Israel, MD
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chu-Pak Lau, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Capucci, MD
Organizational Affiliation
Ospedale Clinic, Piacenza Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
32701364
Citation
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.
Results Reference
derived
PubMed Identifier
29764671
Citation
Perera 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.
Results Reference
derived
PubMed Identifier
24633881
Citation
Brambatti 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.
Results Reference
derived
PubMed Identifier
23356818
Citation
Lau 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.
Results Reference
derived
PubMed Identifier
22698765
Citation
Hohnloser 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.
Results Reference
derived
PubMed Identifier
22236222
Citation
Healey 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. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998.
Results Reference
derived
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Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
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