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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014