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

This study is currently recruiting participants.

Verified by St. Jude Medical, September 2007

First Received: April 3, 2006 Last Updated: September 10, 2007 History of Changes

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00311168

Purpose

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.

Condition	Intervention	Phase
Bradycardia	Procedure: VIP On vs VIP Off	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Percentage of intrinsic ventricular events

Secondary Outcome Measures:

Incidence of arrhythmias
Percentage of intrinsic and paced events (%PR, %PV, %AR, %AV)
Study-related adverse events
Percentage of auto mode switch events

Estimated Enrollment:	100
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311168

Contacts

Contact: Suma Ramadas, PhD

818-493-3066

SRamadas@sjm.com

Locations

United States, California
St. Jude Medical	Recruiting
Sylmar, California, United States, 91342

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:

Sumati Ramadas, Ph.D.

St. Jude Medical

More Information

No publications provided

Study ID Numbers:	CRD343
Study First Received:	April 3, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00311168 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Bradycardia
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009