Trial Outcomes & Findings for LifeVest Trends Validation Protocol (NCT NCT02149290)

Last Updated: 2020-08-31

Results Overview

Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.

Recruitment status

COMPLETED

Target enrollment

198 participants

Primary outcome timeframe

Three months

Results posted on

2020-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Trends-equipped LifeVest 4000 Subjects using the LifeVest 4000 modified to collect Trends data Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
Overall Study STARTED	198
Overall Study COMPLETED	198
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trends-equipped LifeVest 4000 n=198 Participants Subjects using the LifeVest 4000 modified to collect Trends data Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
Age, Continuous	57 Years STANDARD_DEVIATION 12 • n=198 Participants
Sex: Female, Male Female	47 Participants n=198 Participants
Sex: Female, Male Male	151 Participants n=198 Participants
Region of Enrollment Austria	27 participants n=198 Participants
Region of Enrollment United States	81 participants n=198 Participants
Region of Enrollment Germany	90 participants n=198 Participants
Baseline Left Ventricular Ejection Fraction	23 Ejection Fraction Percentage STANDARD_DEVIATION 7 • n=198 Participants
New York Heart Association Classification Class I	0 Participants n=198 Participants
New York Heart Association Classification Class II	102 Participants n=198 Participants
New York Heart Association Classification Class III	83 Participants n=198 Participants
New York Heart Association Classification Class IV	11 Participants n=198 Participants
New York Heart Association Classification Not Reported	2 Participants n=198 Participants

PRIMARY outcome

Timeframe: Three months

Population: All participants that had at least one recorded in-clinic 6MWT

Outcome measures

Outcome measures
Measure	Clinician Guided 6MWT n=100 Participants Distance-First Clinician guided 6MWT	WCD Guided 6MWT n=78 Participants Distance-First WCD guided 6MWT
Distance Traveled in Six Minute Walk Test	306 meters Standard Deviation 100	296 meters Standard Deviation 100

SECONDARY outcome

Timeframe: Up to 12-14 Weeks of WCD use

Population: All participants

Observe Compliance with completing weekly 6MWT

Outcome measures

Outcome measures
Measure	Clinician Guided 6MWT n=198 Participants Distance-First Clinician guided 6MWT	WCD Guided 6MWT Distance-First WCD guided 6MWT
Compliance With Completing 6MWT Through a Wearable Defibrillator.	79 % of participants completing >= 1 6MWT	—

SECONDARY outcome

Timeframe: Up to 12-14 Weeks of WCD use

Population: All participants.

Observe compliance with answering daily health survey.

Outcome measures

Outcome measures
Measure	Clinician Guided 6MWT n=198 Participants Distance-First Clinician guided 6MWT	WCD Guided 6MWT Distance-First WCD guided 6MWT
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.	93 % of participants completing >= 1 survey	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Three months

Population: All participants

Compliance with WCD use during the study period, and patient-device interactions during a ventricular arrhythmia, if any should occur during the study period.

Outcome measures

Outcome measures
Measure	Clinician Guided 6MWT n=198 Participants Distance-First Clinician guided 6MWT	WCD Guided 6MWT Distance-First WCD guided 6MWT
Patient Interactions With the Wearable Defibrillator	78 Days worn Interval 45.5 to 98.5	—

Adverse Events

Trends-equipped LifeVest 4000

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trends-equipped LifeVest 4000 n=198 participants at risk Subjects using the LifeVest 4000 modified to collect Trends data Trends-equipped LifeVest 4000: LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
Cardiac disorders Tachycardia	1.5% 3/198 • Number of events 4 • During the 12-14 weeks of WCD use All adverse events during the study period whether or not considered related to the participant's participation in the research.
Cardiac disorders Dyspnea	0.51% 1/198 • Number of events 1 • During the 12-14 weeks of WCD use All adverse events during the study period whether or not considered related to the participant's participation in the research.
Cardiac disorders Myocardial Infarction	0.51% 1/198 • Number of events 1 • During the 12-14 weeks of WCD use All adverse events during the study period whether or not considered related to the participant's participation in the research.

Other adverse events

Adverse event data not reported

Additional Information

VP of Medical Affairs

ZOLL LifeVest

Phone: 412-968-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place