Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00289289
First received: February 7, 2006
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention
Atrial Fibrillation
Tachycardia, Supraventricular
Arrhythmia
Bradycardia
Device: Intervention Pacing Features

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month [ Time Frame: 6-months (per Intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (per Intervention) ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months (per Intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (per Intervention) ] [ Designated as safety issue: No ]
    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.


Enrollment: 400
Study Start Date: February 2004
Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289289

  Show 38 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: RESPECT Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00289289     History of Changes
Other Study ID Numbers: 217
Study First Received: February 7, 2006
Results First Received: December 21, 2011
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Atrial Fibrillation
Atrial Tachyarrhythmia
Arrhythmia
Bradycardia
Cardiac Pacemaker
IPG Indication
Pacing

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

ClinicalTrials.gov processed this record on October 23, 2014