Back to resultsCardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transthoracic Impedance
Sponsored by
About this trial
This is an interventional device feasibility trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Transthoracic Impedance
Eligibility Criteria
Inclusion Criteria:
Eligible patients will meet all of the following:
- Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) or have a previously implanted St. Jude Medical (SJM) CRT-D system capable of enabling the diagnostic impedance monitoring feature with implant occurring within the last 14 days
- Have had at least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of ≥100% over a 24 hour period
- Have the ability to maintain a patient diary for recording daily weights, symptoms related to heart failure, changes in diuretic therapy, and any unscheduled clinic or hospital visits
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
- Be less than 18 years of age
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization within 40 days of enrollment
- Have had a recent Cerebrovascular Accident or Transient Ischemic Attack within three months of enrollment
- Have a contraindication for an emergency thoracotomy
- Have an indication that requires programming device in atrial pacing mode
- Have permanent (chronic) atrial fibrillation
- Have a capped or inactive right atrial or right ventricular pacing/defibrillator lead
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
- Be pregnant or planning a pregnancy in the next 6-months
- Be currently participating in a clinical investigation that includes an active treatment arm
- Have a life expectancy of less than six months due to any condition
Sites / Locations
- Baptist Health Medical Center
- Glendale Memorial Hospital
- Deborah Heart and Lung
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Transthoracic impedance device implanted.
Outcomes
Primary Outcome Measures
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500838
Brief Title
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
Official Title
CRT-D Based Impedance Monitoring Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.
Detailed Description
This is a multi-center feasibility study intended to collect information on changes in intra-thoracic impedance measurements from CRT-D devices. In order to obtain an intra-thoracic impedance measurement, the device delivers a subthreshold impulse that measures the resistance between two electrodes.
At the programmed interval, measurements will be obtained between six different lead configurations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization Therapy, Transthoracic Impedance
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Transthoracic impedance device implanted.
Intervention Type
Device
Intervention Name(s)
Transthoracic Impedance
Intervention Description
Impedance measures will be automatically collected via the device
Primary Outcome Measure Information:
Title
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible patients will meet all of the following:
Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) or have a previously implanted St. Jude Medical (SJM) CRT-D system capable of enabling the diagnostic impedance monitoring feature with implant occurring within the last 14 days
Have had at least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of ≥100% over a 24 hour period
Have the ability to maintain a patient diary for recording daily weights, symptoms related to heart failure, changes in diuretic therapy, and any unscheduled clinic or hospital visits
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
Be less than 18 years of age
Have had a recent myocardial infarction, unstable angina or cardiac revascularization within 40 days of enrollment
Have had a recent Cerebrovascular Accident or Transient Ischemic Attack within three months of enrollment
Have a contraindication for an emergency thoracotomy
Have an indication that requires programming device in atrial pacing mode
Have permanent (chronic) atrial fibrillation
Have a capped or inactive right atrial or right ventricular pacing/defibrillator lead
Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Be pregnant or planning a pregnancy in the next 6-months
Be currently participating in a clinical investigation that includes an active treatment arm
Have a life expectancy of less than six months due to any condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Stephen Greer, MD
Organizational Affiliation
Baptist Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Glendale Memorial Hospital
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Deborah Heart and Lung
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
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