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

NCT00848445 | Completed Phase 4

• 1 other identifier: CAFÉ
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

APP and VRR on

EXPERIMENTAL

APP and VRR turned on at 2 week visit

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

APP and VRR off

ACTIVE COMPARATOR

APP and VRR turned off

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

Interventions

Guidant Pulsar Max II or Insignia Plus DR DEVICE

market approved pacemaker. programmed per protocol

APP and VRR off; APP and VRR on

Atrial pacing preference turned on or off DEVICE

programing changes in the device

APP and VRR off; APP and VRR on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawrence Sterns, MD

  Victoria Cardiac Arrythmia trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: October 1, 2002
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 12, 2021

Record last verified: 2021-05