Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Guidant Pulsar Max II or Insignia Plus DR; Device: Atrial pacing preference turned on or off

• Registration Number: NCT00848445
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia Plus DR have an effect on the occurance of AF in patients with no prior history of AF

Detailed Description

This multi-centre, randomized, cross-over, prospective study will evaluate the occurrence of AF with AF pacing therapies programmed on (APP and VRR) and with AF therapies programmed off (APP and VRR) in patients with no known prior history of AF (all patients have a pacing indication). The occurrence of AF as well as time to first event and AF burden (frequecy and duration).

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• No prior history of AF or atrial flutter, primary indication of SSS or AV block for dual chamber pacemaker, confidentiality agreement signed and dated before implant, available for follow-up at the study centre where they were enrolled at the protocol defined intervals, willing and capable of participating in all testing associated with the study, on stable regime of arrhythmia management drugs.

Exclusion Criteria

• Documented history of AF or atrial flutter, clinically significant ventricular arrhythmias, < 18 yrs old, life expectancy < 1 year or expectation of heart transplantation during the study period, likely to or have received a mechanical tricuspid valve during the study, enrolled in other cardiovascular studies, women who are pregnant, inability or refusal to sign Patient Confidentiality Agreement, inability or refusal to complete the follow-up schedule at the study centre in which they were enrolled, exhibit arrhythmias due to reversible cause eg, digitalis toxicity, hypoxia, transient electrolyte imbalance, acute myocardial infarction or electrocution.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
APP and VRR on	Guidant Pulsar Max II or Insignia Plus DR	APP and VRR turned on at 2 week visit
APP and VRR on	Atrial pacing preference turned on or off	APP and VRR turned on at 2 week visit
APP and VRR off	Atrial pacing preference turned on or off	APP and VRR turned off
APP and VRR off	Guidant Pulsar Max II or Insignia Plus DR	APP and VRR turned off

Primary Outcome Measures

Name	Time	Method
To compare the occurrence of AF (>350 bpm) during a period when AF pacing therapies are programmed on (APP and VRR) and during when AF therapies are programmed off.	one year

Secondary Outcome Measures

Name	Time	Method
To compare AF burden between patients with AF therapies programmed on (APP and VRR) and patients with AF pacing therapies turned off (APP and VRR). Burden is defined as the product of the number of AF events and duration of events. To compare the time to	one year