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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187239
First received: September 10, 2005
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Arrhythmia
Device: Autointrinsic Conduction Search Algorithm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary endpoint is the percentage of intrinsic ventricular events. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Frequency of inappropriate ICD therapy during AT/AF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency of appropriate ICD therapy for VT/VF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Study related adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: July 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AICS On
Patients in this arm have Autointrinsic conduction search programmed ON.
Device: Autointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
No Intervention: AICS Off
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.
Device: Autointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00187239

Locations
United States, New Jersey
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Zaffer Syed, MS St. Jude Medical
  More Information

No publications provided

Responsible Party: Director, Scientific Studies, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187239     History of Changes
Other Study ID Numbers: CRD292
Study First Received: September 10, 2005
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
ICDs
Ventricular pacing
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 RV ≤25% of the time as determined by the device diagnostics.
Patient is medically stable.

ClinicalTrials.gov processed this record on October 16, 2014