Heart FailureNCT00500838
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
A study testing Transthoracic Impedance in people with Heart Failure, run by Abbott Medical Devices at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Transthoracic Impedance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Deborah Heart and Lung
Browns Mills, New Jersey, 08015
Medical University of South Carolina
Charleston, South Carolina, 29401
Glendale Memorial Hospital
Glendale, California, 91204
Baptist Health Medical Center
Little Rock, Arkansas, 72205
About this study
Official title: CRT-D Based Impedance Monitoring Feasibility Study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Transthoracic Impedance
- Keywords
- Cardiac Resynchronization Therapy, Transthoracic Impedance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic ImpedanceDevice
Impedance measures will be automatically collected via the device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transthoracic impedance device implanted. Receives: Device: Transthoracic Impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G. Stephen Greer, MD, Principal investigator, Baptist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500838
- Sponsor's protocol ID
- 40004384
- Status last verified
- Jan 2019
- First submitted
- 11 Jul 2007
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRT-D Based Impedance Monitoring Feasibility Study
- ClinicalTrials.gov ID
- NCT00500838
- Acronym / sponsor ID
- 40004384
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, Transthoracic Impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Transthoracic ImpedanceTransthoracic impedance device implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic ImpedanceImpedance measures will be automatically collected via the device | Device | 1 |
Primary outcome
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Stephen Greer, MD principal investigator
Baptist Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Impedance in people with Heart Failure, run by Abbott Medical Devices at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.