FAST (Fluid Accumulation Status Trial)

October 5, 2010 updated by: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Fluid Status Monitoring (OptiVol™)

Study Type

Interventional

Enrollment (Actual)

156

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF Time Frame: 3 days pre-admission and 3 days post-discharge	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 Time Frame: 1 day pre and 1 day post-outpatient visit	Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.	1 day pre and 1 day post-outpatient visit
Number of Adverse Events Time Frame: 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	From enrollment to study exit (up to 36 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria