Clinical trial NCT00916929: Detect Fluid Early From Intra-thoracic Impedance Monitoring
Official title: Detect Fluid Early From Intra-thoracic Impedance Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.


Eligibility criteria: Inclusion Criteria:

* Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
* Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Exclusion Criteria:

* History of kidney disease requiring hemodialysis
* Refractory end stage heart failure

Primary outcomes:
measure: False Positive Rate
timeFrame: 6-months
Secondary outcomes:
measure: Sensitivity
timeFrame: 6-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology, PA
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Cardiology Clinic, PA
state: Arkansas
city: Glendale
country: United States
facility: Glendale Memorial Hospital and MC
state: California
city: Northridge
country: United States
facility: Cardiac Rhythm Specialists, Inc
state: California
city: Colorado Springs
country: United States
facility: Colorado Cardiac Alliance, LLC
state: Colorado
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center
state: Florida
city: Orlando
country: United States
facility: Orlando Heart Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardiovascular HC Found. (Sparrow Research)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Associated Cardiovascular Consultants
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospital / Cornell University
state: New York
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Fairfield
country: United States
facility: Mercy Hospital Fairfield
state: Ohio
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: St Thomas Hospital
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bellevue
country: United States
facility: The Hope Heart Institute
state: Washington
Study officials:
affiliation: Massachusetts General Hospital
name: Edwin K Heist, MD, PhD
role: STUDY_CHAIR
References: