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FAST (Fluid Accumulation Status Trial)

Primary Purpose

Congestive Heart Failure, Cardiomyopathy, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fluid Status Monitoring (OptiVol™)
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure focused on measuring Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alaska Cardiovascular Research Foundation
  • Palm Beach Heart Institute
  • Fort Wayne Cardiology
  • Genesis Medical Center
  • Michigan Cardiovascular Institute
  • North Shore University Hospital
  • Duke University Medical Center
  • Cleveland Clinic Foundation Department of Hear Failure/Transplantation
  • The Ohio State University Hospital
  • The Pavillion at Doylestown Hospital
  • Texas Cardiac Arrhythmia Research
  • Intermountain Medical Center
  • University of Calgary/Foothills Hospital
  • Kingston General Hospital
  • Queen Mary Hospital
  • Prince of Wales Hospital/The Chinese University of Hong Kong

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
February 7, 2006
Last Updated
October 5, 2010
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00289276
Brief Title
FAST (Fluid Accumulation Status Trial)
Official Title
FAST (Fluid Accumulation Status Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Cardiomyopathy, Dyspnea, Pulmonary Edema, Heart Diseases
Keywords
Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Fluid Status Monitoring (OptiVol™)
Intervention Description
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
Primary Outcome Measure Information:
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.
Secondary Outcome Measure Information:
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
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
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Alaska Cardiovascular Research Foundation
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Palm Beach Heart Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Fort Wayne Cardiology
City
Ft. Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Michigan Cardiovascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Pavillion at Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Calgary/Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7V 2V7
Country
Canada
Facility Name
Queen Mary Hospital
City
Pok Fu Lam
State/Province
Hong Kong
Country
China
Facility Name
Prince of Wales Hospital/The Chinese University of Hong Kong
City
Shatin
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

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FAST (Fluid Accumulation Status Trial)

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