FAST (Fluid Accumulation Status Trial)

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00289276
• Collaborator: (none)
• Enrollment: 156
• Locations: 16
• Patients Per Site: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure; Cardiomyopathy; Dyspnea; Pulmonary Edema; Heart Diseases	Device: Fluid Status Monitoring (OptiVol™)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: FAST (Fluid Accumulation Status Trial)
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Apr 1, 2008

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With at Least 30 Days of Daily Impedance Measurements [Up to 36 months.]

   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.

Secondary Outcome Measures

1. Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF [3 days pre-admission and 3 days post-discharge]

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

2. Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF [1 day pre and 1 day post-outpatient visit]

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

3. Number of Adverse Events [From enrollment to study exit (up to 36 months).]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Cardiovascular Research Foundation	Anchorage	Alaska	United States	99508
2	Palm Beach Heart Institute	Atlantis	Florida	United States	33462
3	Fort Wayne Cardiology	Ft. Wayne	Indiana	United States	46805
4	Genesis Medical Center	Davenport	Iowa	United States	52803
5	Michigan Cardiovascular Institute	Saginaw	Michigan	United States	48601
6	North Shore University Hospital	Manhasset	New York	United States	11030
7	Duke University Medical Center	Durham	North Carolina	United States	27710
8	Cleveland Clinic Foundation Department of Hear Failure/Transplantation	Cleveland	Ohio	United States	44195
9	The Ohio State University Hospital	Columbus	Ohio	United States	43210
10	The Pavillion at Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
11	Texas Cardiac Arrhythmia Research	Austin	Texas	United States	78758
12	Intermountain Medical Center	Salt Lake City	Utah	United States	84157
13	University of Calgary/Foothills Hospital	Calgary	Alberta	Canada	T2N 4N1
14	Kingston General Hospital	Kingston	Ontario	Canada	K7V 2V7
15	Queen Mary Hospital	Pok Fu Lam	Hong Kong	China
16	Prince of Wales Hospital/The Chinese University of Hong Kong	Shatin	Hong Kong	China

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00289276
• Other Study ID Numbers: 228
• First Posted: Feb 9, 2006
• Last Update Posted: Oct 13, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Cardiomyopathy; Ventricular Ejection Fraction; Congestive Heart Failure; Impedance
• Additional relevant MeSH terms: Dyspnea; Pulmonary Edema; Heart Failure; Heart Diseases; Cardiomyopathies

Study Results

Participant Flow

Recruitment Details	There were two parts to the FAST study. The first part was called FAST Pivotal and the second part was called FAST Expansion. Subjects were enrolled in the FAST study from November 2003 through September 2007. Subject follow-ups were complete and all subjects were exited by April 2008.
Pre-assignment Detail	None of the subjects in FAST Pivotal were included in FAST Expansion.

Arm/Group Title	FAST Pivotal	FAST Expansion
Arm/Group Description	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.	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.
Period Title: First Part of FAST Study (Pivotal)
STARTED	47	0
COMPLETED	47	0
NOT COMPLETED	0	0
Period Title: First Part of FAST Study (Pivotal)
STARTED	0	109
COMPLETED	0	106
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	FAST Pivotal	FAST Expansion	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	47	109	156
Age (Count of Participants)
<=18 years	0 0%	0 0%	0.0 0%
Between 18 and 65 years	15 31.9%	29 26.6%	44.0 28.2%
>=65 years	32 68.1%	80 73.4%	112.0 71.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.8 (10.5)	69.6 (11.1)	69.4 (10.88)
Sex: Female, Male (Count of Participants)
Female	10 21.3%	26 23.9%	36.0 23.1%
Male	37 78.7%	83 76.1%	120.0 76.9%
Region of Enrollment (participants) [Number]
United States	41 87.2%	90 82.6%	131.0 84%
Canada	6 12.8%	5 4.6%	11.0 7.1%
China	0 0%	14 12.8%	14.0 9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With at Least 30 Days of Daily Impedance Measurements
Description	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.
Time Frame	Up to 36 months.

Outcome Measure Data

Analysis Population Description

Includes all enrolled participants.

Arm/Group Title	FAST Pivotal	FAST Expansion
Arm/Group Description	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.	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.
Measure Participants	47	109
Number [participants]	47 100%	106 97.2%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FAST Pivotal	FAST Expansion
Arm/Group Description	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.	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.
Measure Participants	5	23
Mean (Full Range) [Ohms]	2.50	2.93

3. Secondary Outcome

Title	Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF
Description	Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.
Time Frame	1 day pre and 1 day post-outpatient visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FAST Pivotal	FAST Expansion
Arm/Group Description	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.	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.
Measure Participants	1	4
Mean (Full Range) [Ohms]	6.00	0.00

4. Secondary Outcome

Title	Number of Adverse Events
Description	All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
Time Frame	From enrollment to study exit (up to 36 months).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FAST Pivotal	FAST Expansion
Arm/Group Description	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.	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.
Measure Participants	41	94
Number [Adverse Events]	154	421

Adverse Events

Time Frame	From enrollment to study exit (up to 36 months).
Adverse Event Reporting Description	For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
Arm/Group Title	FAST Pivotal		FAST Expansion
Arm/Group Description	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.		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.
All Cause Mortality
	FAST Pivotal		FAST Expansion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	FAST Pivotal		FAST Expansion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/47 (70.2%)		76/109 (69.7%)
Gastrointestinal disorders
Other: Small Bowel Obstruction	0/47 (0%)	0	1/109 (0.9%)	1
General disorders
Arm/Hand Swelling	0/47 (0%)	0	1/109 (0.9%)	1
Atrial Fibrillation	0/47 (0%)	0	5/109 (4.6%)	5
Back Pain/Discomfort	0/47 (0%)	0	1/109 (0.9%)	1
Cancer	2/47 (4.3%)	2	1/109 (0.9%)	1
Cardiomyopathy	0/47 (0%)	0	3/109 (2.8%)	3
Chest Pain/Angina Pectoris	1/47 (2.1%)	1	6/109 (5.5%)	6
Chest Pressure/Tightness	1/47 (2.1%)	1	1/109 (0.9%)	1
Chronic Obstructive Pulmonary Disease	0/47 (0%)	0	2/109 (1.8%)	2
Cold/Flu	0/47 (0%)	0	1/109 (0.9%)	1
Dehydration	1/47 (2.1%)	1	1/109 (0.9%)	1
Diabetes	0/47 (0%)	0	2/109 (1.8%)	2
Fatigue/Tiredness	1/47 (2.1%)	1	1/109 (0.9%)	1
Heart Failure Decompensation	10/47 (21.3%)	16	28/109 (25.7%)	63
Hypokalemia	0/47 (0%)	0	1/109 (0.9%)	1
Hypotension	0/47 (0%)	0	3/109 (2.8%)	3
Ischemic Heart Disease	0/47 (0%)	0	1/109 (0.9%)	1
Lead Conductor Fracture	0/47 (0%)	0	1/109 (0.9%)	1
Lead Dislodgment	0/47 (0%)	0	1/109 (0.9%)	1
Muscle Stimulation - Diaphragm	1/47 (2.1%)	1	1/109 (0.9%)	1
Myocardial Infarction	1/47 (2.1%)	1	2/109 (1.8%)	2
Other: Aberrantly Conducted Rhythm	0/47 (0%)	0	1/109 (0.9%)	1
Other: Acute Cystitis	1/47 (2.1%)	1	0/109 (0%)	0
Other: Amiodarone Toxicity	0/47 (0%)	0	1/109 (0.9%)	1
Other: Anemia	1/47 (2.1%)	1	1/109 (0.9%)	3
Other: Arm Pain	0/47 (0%)	0	1/109 (0.9%)	1
Other: Battery at Elective Replacement Indicator	3/47 (6.4%)	3	29/109 (26.6%)	29
Other: COAG - Negative Staphylococcus Bacteremia	1/47 (2.1%)	1	0/109 (0%)	0
Other: Cardiac Arrest	0/47 (0%)	0	1/109 (0.9%)	1
Other: Cataracts	0/47 (0%)	0	2/109 (1.8%)	2
Other: Cholecystitis	0/47 (0%)	0	1/109 (0.9%)	1
Other: Clostidium Difficile Colitis Infection	0/47 (0%)	0	1/109 (0.9%)	1
Other: Cushing's Syndrome	0/47 (0%)	0	1/109 (0.9%)	1
Other: Diverticular Disease	1/47 (2.1%)	1	0/109 (0%)	0
Other: Effusion of Right Knee Joint	0/47 (0%)	0	1/109 (0.9%)	1
Other: Enlarged Prostate	0/47 (0%)	0	1/109 (0.9%)	1
Other: Epicardial Lead Placement in Lateral Wall-Poor Placement	0/47 (0%)	0	1/109 (0.9%)	1
Other: Fall	0/47 (0%)	0	2/109 (1.8%)	2
Other: Fractured Femur	1/47 (2.1%)	1	0/109 (0%)	0
Other: Gastrointestinal Bleed	0/47 (0%)	0	2/109 (1.8%)	2
Other: Head Injury	0/47 (0%)	0	1/109 (0.9%)	1
Other: High INR	0/47 (0%)	0	1/109 (0.9%)	1
Other: Inappropriate Shock	0/47 (0%)	0	1/109 (0.9%)	1
Other: Indigestion	1/47 (2.1%)	1	0/109 (0%)	0
Other: Infected Carbuncle	0/47 (0%)	0	1/109 (0.9%)	1
Other: Infected Fistula (gortex) Right Arm	1/47 (2.1%)	1	0/109 (0%)	0
Other: Infected Sebaceous Cyst	0/47 (0%)	0	1/109 (0.9%)	1
Other: Infection	0/47 (0%)	0	1/109 (0.9%)	1
Other: Inguinal Hernia	0/47 (0%)	0	1/109 (0.9%)	1
Other: Iron Deficiency Anemia / GI Bleed	0/47 (0%)	0	1/109 (0.9%)	1
Other: Kidney Stones	0/47 (0%)	0	1/109 (0.9%)	1
Other: Left Indirect Inguinal Hernia	0/47 (0%)	0	1/109 (0.9%)	1
Other: Leg Cramps	0/47 (0%)	0	1/109 (0.9%)	1
Other: Marquis Battery Field Action	14/47 (29.8%)	14	5/109 (4.6%)	5
Other: Melena	0/47 (0%)	0	1/109 (0.9%)	1
Other: Non-functioning Fistula	1/47 (2.1%)	1	0/109 (0%)	0
Other: Osteoarthritis	0/47 (0%)	0	1/109 (0.9%)	1
Other: Pain/Swelling Elbows Bilaterally	0/47 (0%)	0	1/109 (0.9%)	1
Other: Pancreatitis	0/47 (0%)	0	1/109 (0.9%)	1
Other: Peptic Ulcers	0/47 (0%)	0	1/109 (0.9%)	1
Other: Poorly Functioning Fistula	1/47 (2.1%)	3	0/109 (0%)	0
Other: Prostate Enlargement	0/47 (0%)	0	1/109 (0.9%)	1
Other: Prostate Problems	0/47 (0%)	0	1/109 (0.9%)	1
Other: Renal Colic	0/47 (0%)	0	1/109 (0.9%)	1
Other: Right Carotid Artery Stenosis	1/47 (2.1%)	1	0/109 (0%)	0
Other: SVT-Classified as VT with Therapies Delivered	0/47 (0%)	0	1/109 (0.9%)	1
Other: Sepsis	0/47 (0%)	0	1/109 (0.9%)	1
Other: Sepsis Syndrome	0/47 (0%)	0	1/109 (0.9%)	1
Other: Severe Anemia	1/47 (2.1%)	1	1/109 (0.9%)	1
Other: Small Bowel Malformation	1/47 (2.1%)	1	0/109 (0%)	0
Other: Stenosis of the Transposed Vessilic Vein	1/47 (2.1%)	1	0/109 (0%)	0
Other: Subclavian Artery Stenosis	0/47 (0%)	0	1/109 (0.9%)	1
Other: Urinary Tract Infection	0/47 (0%)	0	3/109 (2.8%)	3
Other: Uterine Ablation	1/47 (2.1%)	1	0/109 (0%)	0
Other: Weight Loss, Night Sweats, Chills	0/47 (0%)	0	1/109 (0.9%)	1
Other: Worsening Osteoarthritis	0/47 (0%)	0	1/109 (0.9%)	1
Oversensing	1/47 (2.1%)	1	0/109 (0%)	0
Peripheral Vascular Disease	1/47 (2.1%)	1	1/109 (0.9%)	1
Pneumonia	1/47 (2.1%)	1	6/109 (5.5%)	8
Premature Battery Failure	5/47 (10.6%)	5	0/109 (0%)	0
Rash	0/47 (0%)	0	1/109 (0.9%)	1
Renal Failure	2/47 (4.3%)	2	10/109 (9.2%)	10
Stroke/CVA	1/47 (2.1%)	1	1/109 (0.9%)	1
Suspected Generator/ICD Failure	0/47 (0%)	0	1/109 (0.9%)	1
Syncope	0/47 (0%)	0	1/109 (0.9%)	1
Thrombosis	0/47 (0%)	0	1/109 (0.9%)	1
Ventricular Tachycardia	0/47 (0%)	0	2/109 (1.8%)	6
Other (Not Including Serious) Adverse Events
	FAST Pivotal		FAST Expansion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/47 (42.6%)		52/109 (47.7%)
General disorders
Bronchitis	0/47 (0%)	0	6/109 (5.5%)	6
Chest Pain/Angina Pectoris	0/47 (0%)	0	8/109 (7.3%)	8
Cold/Flu	5/47 (10.6%)	5	14/109 (12.8%)	16
Dizziness	6/47 (12.8%)	6	6/109 (5.5%)	7
Dyspnea/Shortness of Breath	4/47 (8.5%)	4	8/109 (7.3%)	8
Fatigue/Tiredness	4/47 (8.5%)	4	0/109 (0%)	0
Heart Failure Decompensation	4/47 (8.5%)	4	11/109 (10.1%)	13
Other: Battery at Elective Replacement Indicator	0/47 (0%)	0	7/109 (6.4%)	7
Other: Fall	3/47 (6.4%)	4	0/109 (0%)	0
Ventricular Tachycardia	3/47 (6.4%)	3	9/109 (8.3%)	14

Limitations/Caveats

This was a characterization study with no descriptive statistical analysis. The results reported were counts of subjects with impedance data available as applicable for each objective.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.