N/A N=47 Double-blind Diagnostic

FAST (Fluid Accumulation Status Trial)

Congestive Heart Failure · Cardiomyopathy · Dyspnea · Pulmonary Edema · Heart Diseases

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View on ClinicalTrials.gov: NCT00289276 ↗

Enrolled (actual)

Serious AEs

69.9%

Results posted

Sep 2010

Primary outcome: Primary: Number of Subjects With at Least 30 Days of Daily Impedance Measurements — 47; 106 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fluid Status Monitoring (OptiVol™) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With at Least 30 Days of Daily Impedance Measurements	47; 106	—
SECONDARY Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF	2.50; 2.93	—
SECONDARY Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF	6.00; 0.00	—
SECONDARY Number of Adverse Events	154; 421	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.