Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

NCT00256152 | Completed Phase 4

• 1 other identifier: CRD291
• Study Type: interventional
• Target: 2,580
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Atrial Fibrillation

Keywords

Atrial fibrillation; Pacemaker; AF suppression pacing; Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease

Outcome Measures

Primary Outcomes (2)

• Composite of ischemic stroke & Non-CNS systemic embolism

  3 years

• Symptomatic or Asymptomatic AT documented by ECG

  3 years

Secondary Outcomes (1)

• Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death

  3 years

Study Arms (2)

AF Suppression OFF

NO INTERVENTION

AF Suppression ON

EXPERIMENTAL

Device: AF Suppression Pacing Algorithm

Interventions

AF Suppression Pacing Algorithm DEVICE

AF Suppression ON

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Population Health Research Institute: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (6)

• 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.

  PMID: 32701364 DERIVED

• 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.

  PMID: 29764671 DERIVED

• 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.

  PMID: 24633881 DERIVED

• 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.

  PMID: 23356818 DERIVED

• 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.

  PMID: 22698765 DERIVED

• 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.

  PMID: 22236222 DERIVED

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Connolly, MD

  McMaster University

  STUDY CHAIR

• Stephan Hohnloser, MD

  Goethe University

  STUDY CHAIR

• Carlos Morillo, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jeff Healey, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Carsten Israel, MD

  Goethe University

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Chu-Pak Lau, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Alessandro Capucci, MD

  Ospedale Clinic, Piacenza Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: November 21, 2005
• Study Start: September 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

CA (1)