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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00148967
First received: September 7, 2005
Last updated: November 20, 2006
Last verified: November 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Boston Scientific Corporation:
right ventricular pacing
implantable cardioverter defibrillator

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013