Back to resultsAtrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study - (CAFE)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Guidant Pulsar Max II or Insignia Plus DR
Atrial pacing preference turned on or off
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
APP and VRR on
APP and VRR off
Arm Description
APP and VRR turned on at 2 week visit
APP and VRR turned off
Outcomes
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.
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
Full Information
NCT ID
NCT00848445
First Posted
February 19, 2009
Last Updated
May 10, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00848445
Brief Title
Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -
Acronym
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 -
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2002 (Actual)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APP and VRR on
Arm Type
Experimental
Arm Description
APP and VRR turned on at 2 week visit
Arm Title
APP and VRR off
Arm Type
Active Comparator
Arm Description
APP and VRR turned off
Intervention Type
Device
Intervention Name(s)
Guidant Pulsar Max II or Insignia Plus DR
Intervention Description
market approved pacemaker. programmed per protocol
Intervention Type
Device
Intervention Name(s)
Atrial pacing preference turned on or off
Intervention Description
programing changes in the device
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Sterns, MD
Organizational Affiliation
Victoria Cardiac Arrythmia trials
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -
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