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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148967
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 22, 2006
Information provided by:
Boston Scientific Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Tachycardia Device: Implantable Cardioverter Defibrillator Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 1535 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
Study Start Date : July 2003
Study Completion Date : October 2005

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148967

Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Brian Olshansky, MD University of Iowa
Principal Investigator: John Day, MD Utah Heart Clinic