FAST (Fluid Accumulation Status Trial)

Medtronic

Status: Completed

Conditions: Cardiomyopathy; Dyspnea; Heart Diseases; Pulmonary Edema; Congestive Heart Failure

Treatments: Device: Fluid Status Monitoring (OptiVol™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289276

228

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind