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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256152
• Other study ID #: CRD291
• Status: Completed
• Phase: Phase 4
• Start date: September 2004
• Est. completion date: June 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2580
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension

Intervention

Device:
• AF Suppression Pacing Algorithm

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of ischemic stroke & Non-CNS systemic embolism		3 years
Primary	Symptomatic or Asymptomatic AT documented by ECG		3 years
Secondary	Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death		3 years