FAST (Fluid Accumulation Status Trial)

Medtronic Cardiac Rhythm and Heart Failure156 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

156

Conditions

Congestive Heart Failure Cardiomyopathy Dyspnea Pulmonary Edema Heart Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Alaska Cardiovascular Research Foundation

Anchorage, Alaska, United States

Palm Beach Heart Institute

Atlantis, Florida, United States

Fort Wayne Cardiology

Fort Wayne, Indiana, United States

Genesis Medical Center

Davenport, Iowa, United States

Michigan Cardiovascular Institute

Saginaw, Michigan, United States

North Shore University Hospital

Manhasset, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic Foundation Department of Hear Failure/Transplantation

Cleveland, Ohio, United States

The Ohio State University Hospital

Columbus, Ohio, United States

The Pavillion at Doylestown Hospital

Doylestown, Pennsylvania, United States

...and 6 more locations

Outcomes

Primary Outcomes

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.

Time frame: Up to 36 months.

Secondary Outcomes

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.

Time frame: 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

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

Time frame: 1 day pre and 1 day post-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

Time frame: From enrollment to study exit (up to 36 months).