CRT-D Based Impedance Monitoring Study
This study has been completed.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00500838
First received: July 11, 2007
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: Transthoracic Impedance |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | CRT-D Based Impedance Monitoring Feasibility Study |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- To assess the use of the impedance feature in conjunction with other functions of the CRT-D device [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 75 |
| Study Start Date: | July 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Transthoracic impedance device implanted.
|
Device: Transthoracic Impedance
Impedance measures will be automatically collected via the device
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Eligible patients will meet all of the following:
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D or have a previously implanted 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 HF, 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 (PTCA/stent(s) or CABG) within 40 days of enrollment
- Have had a recent CVA or TIA within three months of enrollment
- Have a contraindication for an emergency thoracotomy
- Have an indication that requires programming device in AAI pacing mode
- Have permanent (chronic) atrial fibrillation
- Have a capped or inactive RA or RV 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500838
Locations
| United States, Arkansas | |
| Baptist Health Medical Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Glendale Memorial Hospital | |
| Glendale, California, United States, 91204 | |
| United States, New Jersey | |
| Deborah Heart and Lung | |
| Browns Mills, New Jersey, United States, 08015 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29401 | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | G. Stephen Greer, MD | Baptist Health |
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00500838 History of Changes |
| Other Study ID Numbers: | 40004384 |
| Study First Received: | July 11, 2007 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Medical:
|
Cardiac Resynchronization Therapy Transthoracic Impedance |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013