Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

NCT00289289 | Completed Results

• 1 other identifier: 217
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 38

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).

Conditions

Atrial Fibrillation; Tachycardia, Supraventricular; Arrhythmia; Bradycardia

Keywords

Atrial Fibrillation; Atrial Tachyarrhythmia; Arrhythmia; Bradycardia; Cardiac Pacemaker; IPG Indication; Pacing

Outcome Measures

Primary Outcomes (1)

• 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

  6-months (per Intervention)

Secondary Outcomes (3)

• Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist

  6 months (per Intervention)

• Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)

  6 months (per Intervention)

• Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden

  6 months (per Intervention)

Study Arms (3)

On-Off

ACTIVE COMPARATOR

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

Off-On

ACTIVE COMPARATOR

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

Non-randomized

NO INTERVENTION

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.

Interventions

Intervention Pacing Features DEVICE

Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.

Off-On; On-Off

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (38)

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Little Rock, Arkansas, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Yuba City, California, United States

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Colorado Springs, Colorado, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Urbana, Illinois, United States

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Indianapolis, Indiana, United States

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Cedar Rapids, Iowa, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Takoma Park, Maryland, United States

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Springfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Clifton, New Jersey, United States

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Morristown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Mineola, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Hershey, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Fort Worth, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Sherbrooke, Quebec, Canada

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MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Supraventricular; Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Limitations and Caveats

The effect of ON programming was not consistent across randomized study period, violating a key assumption of the cross-over study design.

Results Point of Contact

• Title: Jen Lahr
• Organization: Medtronic CRDM Clinical

jen.lahr@medtronic.com

Study Officials

• RESPECT Team

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: February 1, 2004
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: August 8, 2012
• Results First Posted: August 8, 2012

Record last verified: 2012-06

Locations

US (34); CA (4)