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

Primary Purpose

Tachycardia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia focused on measuring right ventricular pacing, implantable cardioverter defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    November 20, 2006
    Sponsor
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00148967
    Brief Title
    INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
    Official Title
    Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tachycardia
    Keywords
    right ventricular pacing, implantable cardioverter defibrillator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1535 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Implantable Cardioverter Defibrillator
    Primary Outcome Measure Information:
    Title
    Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.
    Secondary Outcome Measure Information:
    Title
    The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:
    Title
    The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Olshansky, MD
    Organizational Affiliation
    University of Iowa
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Day, MD
    Organizational Affiliation
    Utah Heart Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22016074
    Citation
    Sullivan RM, Russo AM, Berg KC, Stolen KQ, Seth M, Perschbacher D, Day JD, Olshansky B. Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial. Heart Rhythm. 2012 Mar;9(3):351-8. doi: 10.1016/j.hrthm.2011.10.018. Epub 2011 Oct 19.
    Results Reference
    derived
    PubMed Identifier
    19901194
    Citation
    Ahmadi-Kashani M, Kessler DJ, Day J, Bunch TJ, Stolen KQ, Brown S, Sbaity S, Olshansky B; INTRINSIC RV Study Investigators. Heart rate predicts outcomes in an implantable cardioverter-defibrillator population. Circulation. 2009 Nov 24;120(21):2040-5. doi: 10.1161/CIRCULATIONAHA.108.847608. Epub 2009 Nov 9.
    Results Reference
    derived
    PubMed Identifier
    18996055
    Citation
    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. doi: 10.1016/j.hrthm.2008.09.025. Epub 2008 Sep 27.
    Results Reference
    derived

    Learn more about this trial

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

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