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

Abbott

Status and phase: Completed; Phase 4

Conditions: Hypertension; Atrial Fibrillation

Treatments: Device: AF Suppression Pacing Algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00256152

CRD291

Details and patient eligibility

About

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.

Enrollment: 2,580 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,580 participants in 2 patient groups

AF Suppression OFF

No Intervention group

AF Suppression ON

Experimental group

Treatment:

Device: AF Suppression Pacing Algorithm