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Completed

NCT Number: NCT00187239

Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study

The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
  • At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
  • Patient is medically stable.

Exclusion criteria

  • Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
  • Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
  • Patient is younger than 18 years of age.
  • Patient is pregnant.

Treatment and study plan

Autointrinsic Conduction Search Algorithm

Device

Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.

Primary outcomes

  1. The primary endpoint is the percentage of intrinsic ventricular events.

    Time frame: 3 months

Secondary outcomes

  1. Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes

    Time frame: 3 months

  2. Frequency of inappropriate ICD therapy during AT/AF

    Time frame: 3 months

  3. Frequency of appropriate ICD therapy for VT/VF

    Time frame: 3 months

  4. Study related adverse events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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