FAST (Fluid Accumulation Status Trial) | NCT00289276

Status Module

Name	Type	Description	Arm Group Labels	Other Names
Fluid Status Monitoring (OptiVol™)	Device	Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial

Measure	Description	Time Frame
Number of Subjects With at Least 30 Days of Daily Impedance Measurements	Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.	Up to 36 months.

Measure	Description	Time Frame
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF	Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.	3 days pre-admission and 3 days post-discharge
Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Cardiovascular Research Foundation		Anchorage	Alaska	99508	United States
Palm Beach Heart Institute

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
BG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00047 BG001109 BG002156

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With at Least 30 Days of Daily Impedance Measurements

Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.

Includes all enrolled participants.

Posted

Number

participants

Up to 36 months.

ID	Title	Description
OG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
OG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.

Units	Counts
Participants	OG00047 OG001109

Title

Denominators

Categories

Title	Measurements
	OG00047 OG001106

Secondary

Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF

Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.

All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.

Posted

Mean

Full Range

Ohms

3 days pre-admission and 3 days post-discharge

ID	Title	Description
OG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
OG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.

Units	Counts

Secondary

Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF

Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.

All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.

Posted

Mean

Full Range

Ohms

1 day pre and 1 day post-outpatient visit

ID	Title	Description
OG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
OG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.

Units	Counts

Secondary

Number of Adverse Events

All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.

Posted

Number

Adverse Events

From enrollment to study exit (up to 36 months).

ID	Title	Description
OG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
OG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arm/Hand Swelling	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Atrial Fibrillation	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0015 events5 affected109 at risk
Back Pain/Discomfort	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Cancer	General disorders	Other	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected109 at risk
Cardiomyopathy	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected109 at risk
Chest Pain/Angina Pectoris	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0016 events6 affected109 at risk
Chest Pressure/Tightness	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Chronic Obstructive Pulmonary Disease	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected109 at risk
Cold/Flu	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Dehydration	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Diabetes	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected109 at risk
Fatigue/Tiredness	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Heart Failure Decompensation	General disorders	Other	Systematic Assessment	EG00016 events10 affected47 at risk EG00163 events28 affected109 at risk
Hypokalemia	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Hypotension	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected109 at risk
Ischemic Heart Disease	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Lead Conductor Fracture	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Lead Dislodgment	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Muscle Stimulation - Diaphragm	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Myocardial Infarction	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events2 affected109 at risk
Other: Aberrantly Conducted Rhythm	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Acute Cystitis	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Amiodarone Toxicity	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Anemia	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0013 events1 affected109 at risk
Other: Arm Pain	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Battery at Elective Replacement Indicator	General disorders	Other	Systematic Assessment	EG0003 events3 affected47 at risk EG00129 events29 affected109 at risk
Other: COAG - Negative Staphylococcus Bacteremia	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Cardiac Arrest	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Cataracts	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected109 at risk
Other: Cholecystitis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Clostidium Difficile Colitis Infection	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Cushing's Syndrome	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Diverticular Disease	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Effusion of Right Knee Joint	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Enlarged Prostate	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Epicardial Lead Placement in Lateral Wall-Poor Placement	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Fall	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected109 at risk
Other: Fractured Femur	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Gastrointestinal Bleed	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected109 at risk
Other: Head Injury	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: High INR	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Inappropriate Shock	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Indigestion	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Infected Carbuncle	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Infected Fistula (gortex) Right Arm	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Infected Sebaceous Cyst	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Infection	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Inguinal Hernia	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Iron Deficiency Anemia / GI Bleed	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Kidney Stones	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Left Indirect Inguinal Hernia	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Leg Cramps	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Marquis Battery Field Action	General disorders	Other	Systematic Assessment	EG00014 events14 affected47 at risk EG0015 events5 affected109 at risk
Other: Melena	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Non-functioning Fistula	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Osteoarthritis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Pain/Swelling Elbows Bilaterally	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Pancreatitis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Peptic Ulcers	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Poorly Functioning Fistula	General disorders	Other	Systematic Assessment	EG0003 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Prostate Enlargement	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Prostate Problems	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Renal Colic	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Right Carotid Artery Stenosis	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: SVT-Classified as VT with Therapies Delivered	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Sepsis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Sepsis Syndrome	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Severe Anemia	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Other: Small Bowel Malformation	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Small Bowel Obstruction	Gastrointestinal disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Stenosis of the Transposed Vessilic Vein	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Subclavian Artery Stenosis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Urinary Tract Infection	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected109 at risk
Other: Uterine Ablation	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Other: Weight Loss, Night Sweats, Chills	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Other: Worsening Osteoarthritis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Oversensing	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected109 at risk
Peripheral Vascular Disease	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Pneumonia	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0018 events6 affected109 at risk
Premature Battery Failure	General disorders	Other	Systematic Assessment	EG0005 events5 affected47 at risk EG0010 events0 affected109 at risk
Rash	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Renal Failure	General disorders	Other	Systematic Assessment	EG0002 events2 affected47 at risk EG00110 events10 affected109 at risk
Stroke/CVA	General disorders	Other	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected109 at risk
Suspected Generator/ICD Failure	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Syncope	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Thrombosis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected109 at risk
Ventricular Tachycardia	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0016 events2 affected109 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0016 events6 affected109 at risk
Chest Pain/Angina Pectoris	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0018 events8 affected109 at risk
Cold/Flu	General disorders	Other	Systematic Assessment	EG0005 events5 affected47 at risk EG00116 events14 affected109 at risk
Dizziness	General disorders	Other	Systematic Assessment	EG0006 events6 affected47 at risk EG0017 events6 affected109 at risk
Dyspnea/Shortness of Breath	General disorders	Other	Systematic Assessment	EG0004 events4 affected47 at risk EG0018 events8 affected109 at risk
Fatigue/Tiredness	General disorders	Other	Systematic Assessment	EG0004 events4 affected47 at risk EG0010 events0 affected109 at risk
Heart Failure Decompensation	General disorders	Other	Systematic Assessment	EG0004 events4 affected47 at risk EG00113 events11 affected109 at risk
Other: Battery at Elective Replacement Indicator	General disorders	Other	Systematic Assessment	EG0000 events0 affected47 at risk EG0017 events7 affected109 at risk
Other: Fall	General disorders	Other	Systematic Assessment	EG0004 events3 affected47 at risk EG0010 events0 affected109 at risk
Ventricular Tachycardia	General disorders	Other	Systematic Assessment	EG0003 events3 affected47 at risk EG00114 events9 affected109 at risk

ID	Term
D006333	Heart Failure
D009202	Cardiomyopathies
D004417	Dyspnea
D011654	Pulmonary Edema
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FAST Pivotal	FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.			33	47	20	47
EG001	FAST Expansion	FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.			76	109	52	109