Trial Outcomes & Findings for FAST (Fluid Accumulation Status Trial) (NCT NCT00289276)

Last Updated: 2010-10-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

156 participants

Primary outcome timeframe

Up to 36 months.

Results posted on

2010-10-13

Participant Flow

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.

None of the subjects in FAST Pivotal were included in FAST Expansion.

Participant milestones

Participant milestones
Measure	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.	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.
First Part of FAST Study (Pivotal) STARTED	47	0
First Part of FAST Study (Pivotal) COMPLETED	47	0
First Part of FAST Study (Pivotal) NOT COMPLETED	0	0
Second Part of FAST Study (Expansion) STARTED	0	109
Second Part of FAST Study (Expansion) COMPLETED	0	106
Second Part of FAST Study (Expansion) NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Second Part of FAST Study (Expansion) Death	0	2
Second Part of FAST Study (Expansion) Lost to Follow-up	0	1

Baseline Characteristics

FAST (Fluid Accumulation Status Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FAST Pivotal n=47 Participants 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.	FAST Expansion n=109 Participants 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.	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	29 Participants n=7 Participants	44.0 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	80 Participants n=7 Participants	112.0 Participants n=5 Participants
Age Continuous	68.8 years STANDARD_DEVIATION 10.5 • n=5 Participants	69.6 years STANDARD_DEVIATION 11.1 • n=7 Participants	69.4 years STANDARD_DEVIATION 10.88 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	26 Participants n=7 Participants	36.0 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	83 Participants n=7 Participants	120.0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	90 participants n=7 Participants	131.0 participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants	5 participants n=7 Participants	11.0 participants n=5 Participants
Region of Enrollment China	0 participants n=5 Participants	14 participants n=7 Participants	14.0 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months.

Population: Includes all enrolled participants.

Outcome measures

Outcome measures
Measure	FAST Pivotal n=47 Participants 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.	FAST Expansion n=109 Participants 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.
Number of Subjects With at Least 30 Days of Daily Impedance Measurements	47 participants	106 participants

SECONDARY outcome

Timeframe: 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.

Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.

Outcome measures

Outcome measures
Measure	FAST Pivotal n=5 Participants 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.	FAST Expansion n=23 Participants 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.
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF	2.50 Ohms Interval -7.5 to 10.58	2.93 Ohms Interval -17.17 to 11.08

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	FAST Pivotal n=1 Participants 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.	FAST Expansion n=4 Participants 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.
Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF	6.00 Ohms Interval 6.0 to 6.0	0.00 Ohms Interval -4.5 to 7.0

SECONDARY outcome

Timeframe: 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.

All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

Outcome measures

Outcome measures
Measure	FAST Pivotal n=41 Participants 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.	FAST Expansion n=94 Participants 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.
Number of Adverse Events	154 Adverse Events	421 Adverse Events

Adverse Events

FAST Pivotal

Serious events: 33 serious events

Other events: 20 other events

Deaths: 0 deaths

FAST Expansion

Serious events: 76 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FAST Pivotal n=47 participants at risk 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.	FAST Expansion n=109 participants at risk 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.
General disorders Bronchitis	0.00% 0/47 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	5.5% 6/109 • Number of events 6 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Chest Pain/Angina Pectoris	0.00% 0/47 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	7.3% 8/109 • Number of events 8 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Cold/Flu	10.6% 5/47 • Number of events 5 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	12.8% 14/109 • Number of events 16 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Dizziness	12.8% 6/47 • Number of events 6 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	5.5% 6/109 • Number of events 7 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Dyspnea/Shortness of Breath	8.5% 4/47 • Number of events 4 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	7.3% 8/109 • Number of events 8 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Fatigue/Tiredness	8.5% 4/47 • Number of events 4 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	0.00% 0/109 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Heart Failure Decompensation	8.5% 4/47 • Number of events 4 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	10.1% 11/109 • Number of events 13 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Other: Battery at Elective Replacement Indicator	0.00% 0/47 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	6.4% 7/109 • Number of events 7 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Other: Fall	6.4% 3/47 • Number of events 4 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	0.00% 0/109 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.
General disorders Ventricular Tachycardia	6.4% 3/47 • Number of events 3 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.	8.3% 9/109 • Number of events 14 • From enrollment to study exit (up to 36 months). For this study a serious adverse event was defined as an adverse event which results in invasive treatment or which directly results in the death or serious injury to the subject, or the termination of significant device function regardless of other treatments.

Additional Information

CRDM Core Clinical

Medtronic CRDM Clinical Research

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.
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Restriction type: OTHER