Clinical trial NCT00256152: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Atrial Fibrillation
Keywords: Atrial fibrillation
Pacemaker
AF suppression pacing
Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Population Health Research Institute
First posted: 2005-11-21
Enrollment: 2580
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

1. Age ≥ 65 years
2. History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
3. 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.
4. In pacemaker patients only the primary indication for pacing is sinus or AV node disease.

Exclusion Criteria

1. Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
2. Geographic/social or psychiatric factor likely to interfere with follow-up
3. Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)

Primary outcomes:
measure: Composite of ischemic stroke & Non-CNS systemic embolism
timeFrame: 3 years
measure: Symptomatic or Asymptomatic AT documented by ECG
timeFrame: 3 years
Secondary outcomes:
measure: Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
timeFrame: 3 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart Connolly, MD
role: STUDY_CHAIR
affiliation: Goethe University
name: Stephan Hohnloser, MD
role: STUDY_CHAIR
affiliation: McMaster University
name: Carlos Morillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jeff Healey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Goethe University
name: Carsten Israel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong
name: Chu-Pak Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Clinic, Piacenza Italy
name: Alessandro Capucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.