INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00148967

Purpose

INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.

Condition	Intervention	Phase
Tachycardia	Device: Implantable Cardioverter Defibrillator	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.

Secondary Outcome Measures:

The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:
The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life

Estimated Enrollment:	1535
Study Start Date:	July 2003
Estimated Study Completion Date:	October 2005

Detailed Description:

The purpose of study is to assess whether AVSH will provide benefits of a dual-chamber ICD without the deleterious effects of unnecessary RV pacing. This study will aim to demonstrate that DDDR-AVSH is equal to VVI with respect to mortality and HF hospitalizations.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients who meet VITALITY™AVT® ICD indications
Patients who sign and date a Patient Informed Consent prior to device implant
Patients who remain in the clinical care of the enrolling physician

Exclusion Criteria:

Patients with current indication for CRT-D
Patients who previously had a pacemaker, ICD or CRT-D
Patients with chronic AF
Patients whose life expectancy is <12 months due to other medical conditions
Patients who are expected to receive a heart transplant during the duration of the study
Patients with epicardial pacing leads
Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed
Patients with or who are likely to receive a tricuspid or other valve prosthesis
Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
Patients who are younger than 18 years of age
Patients who are pregnant
Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148967

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Brian Olshansky, MD	University of Iowa
Principal Investigator:	John Day, MD	Utah Heart Clinic

More Information

Publications indexed to this study:

Bunch TJ, Day JD, Olshansky B, Stolen KQ, Mullin CM; INTRINSIC RV Study Investigators. Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality. Heart Rhythm. 2009 Jan;6(1):2-8. Epub 2008 Sep 27.

Study ID Numbers:	CR-CA-051403-T
Study First Received:	September 7, 2005
Last Updated:	November 20, 2006
ClinicalTrials.gov Identifier:	NCT00148967
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

right ventricular pacing
implantable cardioverter defibrillator

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009