CRT-D Based Impedance Monitoring Study - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00500838

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 II

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	CRT-D Based Impedance Monitoring Feasibility Study

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 ]

Estimated Enrollment:	75
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Responsible Party:	St. Jude Medical, CRMD ( Director, Clinical Affairs )
Study ID Numbers:	40004384
Study First Received:	July 11, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00500838
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

Cardiac Resynchronization Therapy
Transthoracic Impedance

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009