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

February 1, 2019 updated by: Abbott Medical Devices

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2580

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: AF Suppression OFF
Experimental: AF Suppression ON
Device: AF Suppression Pacing Algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of ischemic stroke & Non-CNS systemic embolism
Time Frame: 3 years
3 years
Symptomatic or Asymptomatic AT documented by ECG
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Population Health Research Institute

Investigators

  • Principal Investigator: Michael Gold, MD, Medical University of South Carolina
  • Study Chair: Stuart Connolly, MD, McMaster University
  • Study Chair: Stephan Hohnloser, MD, Goethe University
  • Principal Investigator: Carlos Morillo, MD, McMaster University
  • Principal Investigator: Jeff Healey, MD, McMaster University
  • Principal Investigator: Carsten Israel, MD, Goethe University
  • Principal Investigator: Chu-Pak Lau, MD, The University of Hong Kong
  • Principal Investigator: Alessandro Capucci, MD, Ospedale Clinic, Piacenza Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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