FAST (Fluid Accumulation Status Trial)

Heart Diseases Clinical Trial

Official title:

FAST (Fluid Accumulation Status Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289276
• Other study ID #: 228
• Status: Completed
• Phase: N/A
• First received: February 7, 2006
• Last updated: October 5, 2010
• Start date: November 2003

Study information

• Verified date: October 2010
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHong Kong: Department of HealthCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Congestive Heart Failure
• Dyspnea
• Heart Diseases
• Heart Failure
• Pulmonary Edema

Intervention

Device:
• Fluid Status Monitoring (OptiVol™)
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial

Locations

Country	Name	City	State
Canada	University of Calgary/Foothills Hospital	Calgary	Alberta
Canada	Kingston General Hospital	Kingston	Ontario
China	Queen Mary Hospital	Pok Fu Lam	Hong Kong
China	Prince of Wales Hospital/The Chinese University of Hong Kong	Shatin	Hong Kong
United States	Alaska Cardiovascular Research Foundation	Anchorage	Alaska
United States	Palm Beach Heart Institute	Atlantis	Florida
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	Cleveland Clinic Foundation Department of Hear Failure/Transplantation	Cleveland	Ohio
United States	The Ohio State University Hospital	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	The Pavillion at Doylestown Hospital	Doylestown	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Fort Wayne Cardiology	Ft. Wayne	Indiana
United States	North Shore University Hospital	Manhasset	New York
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	Intermountain Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Canada,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 36 months.	No
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.	3 days pre-admission and 3 days post-discharge	No
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.	1 day pre and 1 day post-outpatient visit	No
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	From enrollment to study exit (up to 36 months).	No