Cardiomyopathy, Congestive Heart Failure, Dyspnea, Heart Diseases, Pulmonary Edema
Conditions
Keywords
Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance
Brief 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.
Interventions
DEVICEFluid Status Monitoring (OptiVol™)
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least 30 Days of Daily Impedance Measurements | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF | 3 days pre-admission and 3 days post-discharge | Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization. |
| Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF | 1 day pre and 1 day post-outpatient visit | Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit. |
| Number of Adverse Events | 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 |
Countries
Canada, China, United States
Participant flow
Recruitment details
There were two parts to the FAST study. The first part was called FAST Pivotal and the second part was called FAST Expansion. Subjects were enrolled in the FAST study from November 2003 through September 2007. Subject follow-ups were complete and all subjects were exited by April 2008.
Pre-assignment details
None of the subjects in FAST Pivotal were included in FAST Expansion.
Participants by arm
| Arm | Count |
|---|---|
| FAST Pivotal FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature. | 47 |
| FAST Expansion FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature. | 109 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Part of FAST Study (Expansion) | Death | 0 | 2 |
| Second Part of FAST Study (Expansion) | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | FAST Pivotal | FAST Expansion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 32 Participants | 80 Participants | 112.0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 29 Participants | 44.0 Participants |
| Age Continuous | 68.8 years STANDARD_DEVIATION 10.5 | 69.6 years STANDARD_DEVIATION 11.1 | 69.4 years STANDARD_DEVIATION 10.88 |
| Region of Enrollment Canada | 6 participants | 5 participants | 11.0 participants |
| Region of Enrollment China | 0 participants | 14 participants | 14.0 participants |
| Region of Enrollment United States | 41 participants | 90 participants | 131.0 participants |
| Sex: Female, Male Female | 10 Participants | 26 Participants | 36.0 Participants |
| Sex: Female, Male Male | 37 Participants | 83 Participants | 120.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 47 | 52 / 109 |
| serious Total, serious adverse events | 33 / 47 | 76 / 109 |
Outcome results
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.
Time frame: Up to 36 months.
Population: Includes all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FAST Pivotal | Number of Subjects With at Least 30 Days of Daily Impedance Measurements | 47 participants |
| FAST Expansion | Number of Subjects With at Least 30 Days of Daily Impedance Measurements | 106 participants |
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.
Time frame: 3 days pre-admission and 3 days post-discharge
Population: All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST Pivotal | Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF | 2.50 Ohms |
| FAST Expansion | Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF | 2.93 Ohms |
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.
Time frame: 1 day pre and 1 day post-outpatient visit
Population: All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FAST Pivotal | Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF | 6.00 Ohms |
| FAST Expansion | Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF | 0.00 Ohms |
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
Time frame: From enrollment to study exit (up to 36 months).
Population: Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FAST Pivotal | Number of Adverse Events | 154 Adverse Events |
| FAST Expansion | Number of Adverse Events | 421 Adverse Events |