NCT00311168

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

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

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
12.9 years until next milestone

Results Posted

Study results publicly available

July 19, 2021

Completed
Last Updated

August 12, 2021

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

April 3, 2006

Results QC Date

June 29, 2021

Last Update Submit

July 19, 2021

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Intrinsic Ventricular Events

    This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.

    6 months after randomization

Secondary Outcomes (7)

  • Incidence of Arrhythmias

    6 months after randomization

  • Percentage of Atrial Sensing to Ventricular Sensing (%PR)

    6 months after randomization

  • Percentage of Atrial Sensing to Ventricular Pacing (%PV)

    6 months after randomization

  • Percentage of Atrial Pacing to Ventricular Sensing (%AR)

    6 months after randomization

  • Percentage of Atrial Pacing to Ventricular Pacing (%AV)

    6 months after randomization

  • +2 more secondary outcomes

Study Arms (2)

VIP On, Then VIP Off

EXPERIMENTAL

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

Device: Intervention/treatment

VIP Off, Then VIP On

EXPERIMENTAL

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

Device: Intervention/treatment

Interventions

Intervention/treatmentDEVICE

Device: VIP On Device: VIP Off

VIP Off, Then VIP OnVIP On, Then VIP Off

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Bradycardia

Interventions

MethodsTherapeutics

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Clay Cohorn - Director, Clinical Research
Organization
Abbott
clay.cohorn@abbott.com
469-929-7116

Study Officials

  • Clay Cohorn

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 12, 2021

Results First Posted

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)