Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)

NCT ID: NCT00311168

Last Updated: 2021-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.

Detailed Description

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Conditions

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Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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VIP On, Then VIP Off

Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.

Group Type EXPERIMENTAL

Intervention/treatment

Intervention Type DEVICE

Device: VIP On

Device: VIP Off

VIP Off, Then VIP On

Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.

Group Type EXPERIMENTAL

Intervention/treatment

Intervention Type DEVICE

Device: VIP On

Device: VIP Off

Interventions

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Intervention/treatment

Device: VIP On

Device: VIP Off

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
* At the time of pacemaker implant, VIP™ is programmed "OFF".
* At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
* Patient is medically stable.

Exclusion Criteria

* Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
* Patient is indicated for AF Suppression.
* Patient has persistent or chronic atrial fibrillation.
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is currently participating in another device research study.
* Patient is younger than 18 years of age.
* Patient is pregnant.
* Patients life expectancy is less than 12 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clay Cohorn

Role: STUDY_DIRECTOR

Abbott

Locations

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Abbott

Sylmar, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRD343

Identifier Type: -

Identifier Source: org_study_id

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