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Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

Primary Purpose

Congestive Heart Failure (CHF)

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Ovatio CRT
Sponsored by
ELA Medical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Congestive Heart Failure (CHF) focused on measuring Congestive Heart Failure, Heart Failure, Cardiac Resynchronization Therapy, ICD, Implantable Cardioverter-Defibrillator, Defibrillator

Eligibility Criteria

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

Inclusion Criteria:

  • Accepted indication for ICD implant
  • Severe heart failure (NYHA Class III or IV) at the time of enrollment
  • May have pre-existing ICD, provided subject is on stable, optimal medical regime
  • Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
  • Left-ventricular ejection fraction (LVEF) of 35% or less

Exclusion Criteria:

  • Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
  • Any contraindication for ICD therapy
  • Currently implanted with a lead positioned in or through the coronary sinus
  • Hypertrophic or obstructive cardiomyopathy
  • Acute myocarditis
  • Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
  • Recent or planned cardiac revascularization or coronary angioplasty
  • Correctable valvular disease that is the primary cause of heart failure
  • Mechanical tricuspid valve
  • Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month
  • Systolic blood pressure consistently above 170 mmHg or consistently below 80 mmHg
  • Supine resting heart rate exceeding 100 bpm
  • Receiving continuous IV infusion of positive inotropic therapy or intermittent therapy (IV infusion) more than twice per week
  • Heart transplant recipient
  • Primary pulmonary disease of a severity that might limit the patient's ability to perform a treadmill test
  • Serum creatinine above 3.0 mg/dL
  • Serum hepatic functions at or above three times the upper normal limit
  • Cerebrovascular event within the previous three months
  • Inability to walk or other physical impediments which might prevent the patient from completing a maximum, symptom-limited treadmill test
  • Age of less than 18 years
  • Pregnancy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 10, 2007
    Last Updated
    November 26, 2013
    Sponsor
    ELA Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00528320
    Brief Title
    Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
    Official Title
    Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ELA Medical, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV). Quality of life, adverse events and device success will be analyzed and reported.
    Detailed Description
    ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality. This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (NYHA Class III or IV). Quality of life, adverse events and device success will be analyzed and reported.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congestive Heart Failure (CHF)
    Keywords
    Congestive Heart Failure, Heart Failure, Cardiac Resynchronization Therapy, ICD, Implantable Cardioverter-Defibrillator, Defibrillator

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Ovatio CRT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Accepted indication for ICD implant Severe heart failure (NYHA Class III or IV) at the time of enrollment May have pre-existing ICD, provided subject is on stable, optimal medical regime Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms Left-ventricular ejection fraction (LVEF) of 35% or less Exclusion Criteria: Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing Any contraindication for ICD therapy Currently implanted with a lead positioned in or through the coronary sinus Hypertrophic or obstructive cardiomyopathy Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Recent or planned cardiac revascularization or coronary angioplasty Correctable valvular disease that is the primary cause of heart failure Mechanical tricuspid valve Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month Systolic blood pressure consistently above 170 mmHg or consistently below 80 mmHg Supine resting heart rate exceeding 100 bpm Receiving continuous IV infusion of positive inotropic therapy or intermittent therapy (IV infusion) more than twice per week Heart transplant recipient Primary pulmonary disease of a severity that might limit the patient's ability to perform a treadmill test Serum creatinine above 3.0 mg/dL Serum hepatic functions at or above three times the upper normal limit Cerebrovascular event within the previous three months Inability to walk or other physical impediments which might prevent the patient from completing a maximum, symptom-limited treadmill test Age of less than 18 years Pregnancy

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

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