NCT00187239

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

September 10, 2005

Last Update Submit

February 1, 2019

Conditions

Arrhythmia

Keywords

ICDsVentricular pacingPatient 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.

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (4)

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

    3 months

  • Frequency of inappropriate ICD therapy during AT/AF

    3 months

  • Frequency of appropriate ICD therapy for VT/VF

    3 months

  • Study related adverse events

    3 months

Study Arms (2)

AICS On

ACTIVE COMPARATOR

Patients in this arm have Autointrinsic conduction search programmed ON.

Device: Autointrinsic Conduction Search Algorithm

AICS Off

NO INTERVENTION

Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.

Interventions

Autointrinsic Conduction Search AlgorithmDEVICE

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

AICS On

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zaffer Syed, MS

    Abbott Medical Devices

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

US(1)