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

NCT ID: NCT00256152

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AF Suppression OFF

Group Type: NO_INTERVENTION

No interventions assigned to this group

AF Suppression ON

Group Type: EXPERIMENTAL

AF Suppression Pacing Algorithm

Intervention Type: DEVICE

Interventions

AF Suppression Pacing Algorithm

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Connolly, MD

Role: STUDY_CHAIR

McMaster University

Stephan Hohnloser, MD

Role: STUDY_CHAIR

Goethe University

Carlos Morillo, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jeff Healey, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Carsten Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Michael Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Chu-Pak Lau, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Alessandro Capucci, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Clinic, Piacenza Italy

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32701364 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29764671 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24633881 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23356818 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22698765 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22236222 (View on PubMed)

Other Identifiers

CRD291

Identifier Type: -

Identifier Source: org_study_id