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

Atrial Fibrillation Clinical Trial

— CAFE  

Official title:

the Use of Atrial Fibrillation Pacing Therapies in Patients With no Previous History of Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848445
• Other study ID #: CAFÉ
• Status: Completed
• Phase: Phase 4
• Start date: October 2002
• Est. completion date: November 2007

Study information

• Verified date: May 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Guidant Pulsar Max II or Insignia Plus DR
market approved pacemaker. programmed per protocol
• Atrial pacing preference turned on or off
programing changes in the device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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