Clinical trial NCT00289276: FAST (Fluid Accumulation Status Trial)
Official title: FAST (Fluid Accumulation Status Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Cardiomyopathy
Dyspnea
Pulmonary Edema
Heart Diseases
Keywords: Cardiomyopathy
Ventricular Ejection Fraction
Congestive Heart Failure
Impedance
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. The purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.


Eligibility criteria: Inclusion Criteria:

* Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™.
* Subjects with an ICD placed in the upper part of the left or right side of their chest.
* Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
* Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.

Exclusion Criteria:

* Subjects who are already enrolled in another clinical study.
* Subjects who have received a heart transplant.
* Subjects who are unable or unwilling to follow the study schedule of visits.

Primary outcomes:
measure: Number of Subjects With at Least 30 Days of Daily Impedance Measurements
timeFrame: Up to 36 months.
Secondary outcomes:
measure: Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF
timeFrame: 3 days pre-admission and 3 days post-discharge
measure: Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF
timeFrame: 1 day pre and 1 day post-outpatient visit
measure: Number of Adverse Events
timeFrame: From enrollment to study exit (up to 36 months).
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cardiovascular Research Foundation
state: Alaska
city: Atlantis
country: United States
facility: Palm Beach Heart Institute
state: Florida
city: Ft. Wayne
country: United States
facility: Fort Wayne Cardiology
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Department of Hear Failure/Transplantation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Hospital
state: Ohio
city: Doylestown
country: United States
facility: The Pavillion at Doylestown Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Calgary
country: Canada
facility: University of Calgary/Foothills Hospital
state: Alberta
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Pok Fu Lam
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Shatin
country: China
facility: Prince of Wales Hospital/The Chinese University of Hong Kong
state: Hong Kong
Study officials:
References: