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

NCT ID: NCT00187239

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AICS On

Patients in this arm have Autointrinsic conduction search programmed ON.

Group Type ACTIVE_COMPARATOR

Autointrinsic Conduction Search Algorithm

Intervention Type DEVICE

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

AICS Off

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autointrinsic Conduction Search Algorithm

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

St. Jude Medical

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zaffer Syed, MS

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRD292

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Jewel IDE Study
NCT05201495 COMPLETED NA
Novel ICD Arrhythmia Detection Algorithm
NCT04981496 ACTIVE_NOT_RECRUITING
Minimizing Ventricular Pacing
NCT01611389 UNKNOWN NA