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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00848445
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Device: Guidant Pulsar Max II or Insignia Plus DR
Device: Atrial pacing preference turned on or off
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: the Use of Atrial Fibrillation Pacing Therapies in Patients With no Previous History of Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: October 2002
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APP and VRR on
APP and VRR turned on at 2 week visit
Device: Guidant Pulsar Max II or Insignia Plus DR
market approved pacemaker. programmed per protocol
Device: Atrial pacing preference turned on or off
programing changes in the device
Active Comparator: APP and VRR off
APP and VRR turned off
Device: Guidant Pulsar Max II or Insignia Plus DR
market approved pacemaker. programmed per protocol
Device: Atrial pacing preference turned on or off
programing changes in the device

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848445

Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Lawrence Sterns, MD Victoria Cardiac Arrythmia trials
  More Information

No publications provided

Responsible Party: Dr Lawrence Sterns (PI), Victoria Cardiac Arrythmia Trials
ClinicalTrials.gov Identifier: NCT00848445     History of Changes
Other Study ID Numbers: CAFÉ
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014