Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

June 25, 2012 updated by: Medtronic Cardiac Rhythm and Heart Failure
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
    • Quebec
      • Sherbrooke, Quebec, Canada
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Rancho Mirage, California, United States
      • San Diego, California, United States
      • Yuba City, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Jacksonville, Florida, United States
      • Lakeland, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Decatur, Illinois, United States
      • Urbana, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Cedar Rapids, Iowa, United States
    • Kentucky
      • Louisville, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Maryland
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • New Jersey
      • Clifton, New Jersey, United States
      • Morristown, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Mineola, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Corpus Christi, Texas, United States
      • Fort Worth, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
    • West Virginia
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: On-Off
Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Device: Intervention Pacing Features
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
ACTIVE_COMPARATOR: Off-On
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Device: Intervention Pacing Features
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
NO_INTERVENTION: Non-randomized
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
Time Frame: 6-months (per Intervention)
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
6-months (per Intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist
Time Frame: 6 months (per Intervention)
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.
6 months (per Intervention)
Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)
Time Frame: 6 months (per Intervention)
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.
6 months (per Intervention)
Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden
Time Frame: 6 months (per Intervention)
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.
6 months (per Intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: RESPECT Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (ESTIMATE)

February 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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