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Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

Primary Purpose

First Degree AV Block

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiac resynchronization therapy-defibrillator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for First Degree AV Block focused on measuring Implantable ICD, First Degree AV block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with:
  • QRS width < 120 msec
  • Left ventricular ejection fraction (LVEF) < 35% (no more than 180 days prior to enrollment)
  • NYHA functional class II/III
  • Optimal pharmacological heart failure therapy
  • PR interval >/= 230 msec
  • Ability to tolerate protocol required programming
  • Access to a telephone line compatible with the LATITUDE® Communicator
  • Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study
  • Age 18 or above, or of legal age to give informed consent specific to state and national law
  • Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol

Exclusion Criteria:

  • Previously placed pacemaker, ICD, or CRT device
  • Inability or refusal to sign the Informed Consent Form
  • Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months
  • Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
  • Inability or refusal to comply with the follow-up schedule
  • Have a neuromuscular, orthopedic, or other noncardiac condition that prevents subject from normal unsupported walking for the six minute hall walk test
  • Have surgically uncorrected primary valvular heart disease
  • Second or third degree atrioventricular block (AVB)
  • Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies
  • Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future
  • Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group
  • Women who are pregnant or plan to become pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Device programming modifies AV timing

    Device programming allows intrinsic AV timing.

    Arm Description

    DDD-40-BiV

    VVI-40-RV

    Outcomes

    Primary Outcome Measures

    Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.
    Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 2, 2011
    Last Updated
    June 22, 2017
    Sponsor
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01275833
    Brief Title
    Restoration of Atrioventricular Synchrony Trial
    Acronym
    RESTORE-AV
    Official Title
    Restoration of Atrioventricular Synchrony Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Difficult subject recruitment
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and chronically using echocardiographic and functional measurements.
    Detailed Description
    Same as above.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    First Degree AV Block
    Keywords
    Implantable ICD, First Degree AV block

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Device programming modifies AV timing
    Arm Type
    Experimental
    Arm Description
    DDD-40-BiV
    Arm Title
    Device programming allows intrinsic AV timing.
    Arm Type
    No Intervention
    Arm Description
    VVI-40-RV
    Intervention Type
    Device
    Intervention Name(s)
    Cardiac resynchronization therapy-defibrillator
    Other Intervention Name(s)
    First degree AV block, Long PR interval
    Intervention Description
    Device programming that modifies AV timing
    Primary Outcome Measure Information:
    Title
    Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.
    Description
    Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with: QRS width < 120 msec Left ventricular ejection fraction (LVEF) < 35% (no more than 180 days prior to enrollment) NYHA functional class II/III Optimal pharmacological heart failure therapy PR interval >/= 230 msec Ability to tolerate protocol required programming Access to a telephone line compatible with the LATITUDE® Communicator Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol Exclusion Criteria: Previously placed pacemaker, ICD, or CRT device Inability or refusal to sign the Informed Consent Form Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation Inability or refusal to comply with the follow-up schedule Have a neuromuscular, orthopedic, or other noncardiac condition that prevents subject from normal unsupported walking for the six minute hall walk test Have surgically uncorrected primary valvular heart disease Second or third degree atrioventricular block (AVB) Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group Women who are pregnant or plan to become pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Olshansky, MD
    Organizational Affiliation
    University of Iowa Hospitals
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Day, MD
    Organizational Affiliation
    Intermountain Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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