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

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Abbott

Status

Completed

Conditions

Bradycardia

Treatments

Device: Intervention/treatment

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

135 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

135 participants in 2 patient groups

VIP On, Then VIP Off
Experimental group
Description:
Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.
Treatment:
Device: Intervention/treatment
VIP Off, Then VIP On
Experimental group
Description:
Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.
Treatment:
Device: Intervention/treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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