Back to resultsReducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Primary Purpose
Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention Pacing Features
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Atrial Tachyarrhythmia, Arrhythmia, Bradycardia, Cardiac Pacemaker, IPG Indication, Pacing
Eligibility Criteria
Inclusion Criteria: Subjects with fast and/or slow heartbeats who are in need of dual chamber pacing (pacing in both the atria and ventricles) as determined by their doctor. Subjects who have a history of occasional fast heartbeats originating from the upper heart chambers. Subjects who have experienced at least two symptomatic episodes of fast heartbeats three months prior to enrollment. Subjects that are expected to stay on the same heart medications during the length study. Exclusion Criteria: Subjects who have permanent (chronic) or persistent (not self-terminating) atrial fibrillation (fast heartbeats originating from the upper heart chambers). Subjects who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance. Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
On-Off
Off-On
Non-randomized
Arm Description
Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Subjects that did not have device recorded episodes of atrial tachycardia/atrial fibrillation during the 3 month observation period post-implant did not qualify for randomization but were continued to be followed in the study. There were no programming requirements and symptom activations were not collected.
Outcomes
Primary Outcome Measures
Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed
Secondary Outcome Measures
Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.
Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.
Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.
Full Information
NCT ID
NCT00289289
First Posted
February 7, 2006
Last Updated
June 25, 2012
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00289289
Brief Title
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Official Title
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of breath, dizziness, and others).
Detailed Description
The purpose of the study was to confirm the AT500 intervention pacing effectiveness data previously seen in the ASPECT clinical trial and to gather additional data to understand the effectiveness of the intervention pacing features. Specifically, the goal of the trial is to demonstrate a reduction in frequency in symptomatic atrial tachycardia/atrial fibrillation recurrence with the intervention pacing features in patients with a pacing indication and a history of atrial tachyarrhythmias with atrial pacing leads located in the region of Bachmann's Bundle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
Keywords
Atrial Fibrillation, Atrial Tachyarrhythmia, Arrhythmia, Bradycardia, Cardiac Pacemaker, IPG Indication, Pacing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
On-Off
Arm Type
Active Comparator
Arm Description
Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Arm Title
Off-On
Arm Type
Active Comparator
Arm Description
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Arm Title
Non-randomized
Arm Type
No Intervention
Arm Description
Subjects that did not have device recorded episodes of atrial tachycardia/atrial fibrillation during the 3 month observation period post-implant did not qualify for randomization but were continued to be followed in the study. There were no programming requirements and symptom activations were not collected.
Intervention Type
Device
Intervention Name(s)
Intervention Pacing Features
Intervention Description
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
Primary Outcome Measure Information:
Title
Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
Description
The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed
Time Frame
6-months (per Intervention)
Secondary Outcome Measure Information:
Title
Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
Description
The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.
Time Frame
6 months (per Intervention)
Title
Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
Description
The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.
Time Frame
6 months (per Intervention)
Title
Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
Description
AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.
Time Frame
6 months (per Intervention)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with fast and/or slow heartbeats who are in need of dual chamber pacing (pacing in both the atria and ventricles) as determined by their doctor.
Subjects who have a history of occasional fast heartbeats originating from the upper heart chambers.
Subjects who have experienced at least two symptomatic episodes of fast heartbeats three months prior to enrollment.
Subjects that are expected to stay on the same heart medications during the length study.
Exclusion Criteria:
Subjects who have permanent (chronic) or persistent (not self-terminating) atrial fibrillation (fast heartbeats originating from the upper heart chambers).
Subjects who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance.
Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RESPECT Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Rancho Mirage
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Yuba City
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Decatur
State/Province
Illinois
Country
United States
City
Urbana
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Cedar Rapids
State/Province
Iowa
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Owensboro
State/Province
Kentucky
Country
United States
City
Takoma Park
State/Province
Maryland
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Clifton
State/Province
New Jersey
Country
United States
City
Morristown
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Edmonton
State/Province
Alberta
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
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