Vest Prevention of Early Sudden Death Trial and VEST Registry

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01446965
• Collaborator: Zoll Medical Corporation (Industry)
• Enrollment: 2,348
• Locations: 71
• Arms: 2
• Actual Duration (Months): 131
• Patients Per Site: 33.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Ventricular Dysfunction; Sudden Death; Ventricular Tachycardia; Ventricular Fibrillation	Device: wearable defibrillator	N/A

Detailed Description

In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
• Actual Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wearable defibrillator subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients	Device: wearable defibrillator; LifeVest wearable defibrillator; Other Names: LifeVest wearable cardioverter-defibrillator WCD WD
No Intervention: Conventional treatment subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients

Outcome Measures

Primary Outcome Measures

1. Sudden Death Mortality [three months after myocardial infarction]

   For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.

Secondary Outcome Measures

1. All Cause Mortality [three months after myocardial infarction]

   All deaths, due to any cause

2. Compliance With Wearable Defibrillator Use [three months after myocardial infarction]

   daily wear time of the device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)

• LV ejection fraction ≤35% determined at the following time point:

1. If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI

2. If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI

3. If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG

• Age ≥ 18 years

Exclusion Criteria:

• Existing ICD or indication for an ICD at the time of screening

• Existing unipolar pacemakers/leads

• Chronic renal failure requiring hemodialysis after hospital discharge

• Chest circumference too small or too large for LifeVest garment*

• Participants discharged to an institutional setting with an anticipated stay > 7 days

• Pregnancy

• Inability to consent

• Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Heart Institute	Anchorage	Alaska	United States	99508
2	Cardiovascular Consultants Heart Center	Fresno	California	United States	93720
3	Salinas Valley Memorial Healthcare System	Salinas	California	United States	93901
4	University of California, San Francisco	San Francisco	California	United States	94143
5	University of Colorado	Aurora	Colorado	United States	80045
6	Hartford Hospital	Hartford	Connecticut	United States	06102
7	Christiana Care Health Services	Newark	Delaware	United States	19718
8	University of Florida	Gainesville	Florida	United States	32610
9	Watson Clinic for Research, Inc.	Lakeland	Florida	United States	33805
10	Melbourne Cardiac Resarch Institute	Melbourne	Florida	United States	32901
11	Florida Heart Group/Florida Hospital	Orlando	Florida	United States	32803
12	Advocate Christ Hospital	Oak Lawn	Illinois	United States	60453
13	Lutheran General	Park Ridge	Illinois	United States	60068
14	The Heart Group/Deaconess Hospital	Evansville	Indiana	United States	47713
15	Indiana University	Indianapolis	Indiana	United States	46202
16	St. Vincent Medical Group	Indianapolis	Indiana	United States	46260
17	Western Kentucky Heart and Lung	Bowling Green	Kentucky	United States	42101
18	University of Kentucky Gill Heart Institute	Lexington	Kentucky	United States	40536
19	Ochsner Clinic	New Orleans	Louisiana	United States	70121
20	Tufts Medical Center	Boston	Massachusetts	United States	02111
21	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
22	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
23	University of Massachusetts Memorial	Worcester	Massachusetts	United States	01655
24	The Valley Hospital	Ridgewood	New Jersey	United States	07450
25	Presbyterian Heart Group	Albuquerque	New Mexico	United States	87106
26	Albany Associates in Cardiology	Albany	New York	United States	12205
27	Montefiore Medical Center	Bronx	New York	United States	10467
28	United Health Services	Johnson City	New York	United States	13790
29	Long Island Jewish Hospital	New Hyde Park	New York	United States	11040
30	St. Luke's- Roosevelt Hospital Center	New York	New York	United States	10025
31	Mount Sinai Hospital	New York	New York	United States	10029
32	Lenox Hill Hospital	New York	New York	United States	10075
33	Huntington Hospital	New York	New York	United States	11743
34	University Cardiovascular Associates (Rochester)	Rochester	New York	United States	14626
35	Stony Brook University	Stony Brook	New York	United States	11794
36	University of North Carolina @ Chapel Hill	Chapel Hill	North Carolina	United States	27599
37	Duke University Medical Center	Durham	North Carolina	United States	27710
38	Wake Heart Research	Raleigh	North Carolina	United States	27610
39	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
40	Cleveland Clinic	Cleveland	Ohio	United States	44195
41	University Hospital Case Medical Center	Columbus	Ohio	United States	44106
42	North Ohio Heart Center-North Ohio Research	Elyria	Ohio	United States	44035
43	Cardiovascular Research Center, LLC/Mercy St Vincent	Toledo	Ohio	United States	43608
44	Oklahoma Heart Institute-Hillcrest	Tulsa	Oklahoma	United States	74104
45	Oregon Heart & Vascular	Springfield	Oregon	United States	97477
46	Chambersburg Hospital	Chambersburg	Pennsylvania	United States	17201
47	Geisinger Heart Institute	Danville	Pennsylvania	United States	17822
48	The Guthrie Clinic/Guthrie Medical Group	Sayre	Pennsylvania	United States	18840
49	Brown Medical School-Rhode Island Hospital	Providence	Rhode Island	United States	02903
50	Providence/South Carolina Heart Center	Columbia	South Carolina	United States	29204
51	McLeod Health/Pee Dee Cardiology	Florence	South Carolina	United States	29506
52	Wellmont Holston Valley	Kingsport	Tennessee	United States	37660
53	Turkey Creek Medical Center	Knoxville	Tennessee	United States	37934
54	Baylor University Medical Center	Dallas	Texas	United States	75226
55	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
56	Carilion Clinic	Roanoke	Virginia	United States	24014
57	Cardiac Study Center	Tacoma	Washington	United States	98405
58	Med. Uniklinik Heidelberg	Heidelberg	Deutschland	Germany	69120
59	Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus	Duisburg	Nordrhein-Westfalen	Germany	47169
60	Klinikum Links der Weser gGmbh Klinik	Bremen		Germany	28277
61	Klinikum Göttingen Georg-August-Universität Göttingen	Göttingen		Germany	37099
62	Klinikum der Stadt Ludwigshafen	Ludwigshafen		Germany	67063
63	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz		Germany	55131
64	Universitätsklinikum Mannheim	Mannheim		Germany	68167
65	Gdanski Uniwersytet Medyczny	Gdansk		Poland	80-952
66	Specjalistyczna Poradnia Kardiologiczna	Kielce		Poland	25525
67	Mc Tronik	Lodz		Poland	90-553
68	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie	Rzeszow		Poland	35111
69	II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)	Warsaw		Poland	02-637
70	Medical University of Warsaw	Warsaw		Poland	02097
71	Institute of Cardiology	Warszawa		Poland	04627

Sponsors and Collaborators

• University of California, San Francisco
• Zoll Medical Corporation

Investigators

• Principal Investigator: Jeffrey E Olgin, MD, University of California, San Francisco
• Study Director: Byron K Lee, MD, University of California, San Francisco
• Principal Investigator: Mark J Pletcher, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2017

More Information

Additional Information:

• Linked to VEST/PREDICTS registration: NCT00628966

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01446965
• Other Study ID Numbers: 90D0114; NCT00628966
• First Posted: Oct 5, 2011
• Last Update Posted: Jan 20, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of California, San Francisco: myocardial infarction, acute; myocardial infarction; ventricular dysfunction; death, sudden, cardiac; death, sudden; death; ventricular tachycardia; ventricular fibrillation; defibrillation, electric; cardioversion, electric; electric countershock; defibrillators, external
• Additional relevant MeSH terms: Myocardial Infarction; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Ventricular Fibrillation; Infarction; Death; Death, Sudden

Study Results

Participant Flow

Recruitment Details

From July 2008 through April 2017, the investigators enrolled 2348 participants at 76 sites in the United States, at 24 in Poland, at 6 in Germany, and at 2 in Hungary. One U.S. site was dismissed on June 24, 2014, and the 46 participants at that site were excluded from the analyses, due to irregularities found by the institutional review board at the site. Thus, a total of 2302 participants were included in the analyses (1524 participants in the device group and 778 in the control group).

Arm/Group Title	Wearable Defibrillator	Conventional Treatment
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator	subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Period Title: Randominization
STARTED	1554	794
COMPLETED	1524	778
NOT COMPLETED	30	16
Period Title: Randominization
STARTED	1524	778
Received WCD	1481	0
Never Wore WCD	43	0
Never Given WCD	0	758
Given WCD Out of Protocol	0	20
COMPLETED	1514	766
NOT COMPLETED	10	12

Baseline Characteristics

Arm/Group Title	Wearable Defibrillator	Conventional Treatment	Total
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator	subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients	Total of all reporting groups
Overall Participants	1524	778	2302
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (12.6)	61.4 (12.4)	61.2 (12.6)
Sex: Female, Male (Count of Participants)
Female	413 27.1%	195 25.1%	608 26.4%
Male	1108 72.7%	577 74.2%	1685 73.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	25 1.6%	12 1.5%	37 1.6%
Asian	23 1.5%	14 1.8%	37 1.6%
Native Hawaiian or Other Pacific Islander	1 0.1%	0 0%	1 0%
Black or African American	143 9.4%	75 9.6%	218 9.5%
White	1279 83.9%	636 81.7%	1915 83.2%
More than one race	20 1.3%	14 1.8%	34 1.5%
Unknown or Not Reported	33 2.2%	27 3.5%	60 2.6%
Left ventricular ejection fraction (percentage of total amount of blood) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of total amount of blood]	28.2 (6.1)	28.2 (5.8)	28.2 (6.1)

Outcome Measures

1. Primary Outcome

Title	Sudden Death Mortality
Description	For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.
Time Frame	three months after myocardial infarction

Outcome Measure Data

Analysis Population Description

A total of 2302 participants were included in the analyses.

Arm/Group Title	Wearable Defibrillator	Conventional Treatment
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator	subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Measure Participants	1524	778
Count of Participants [Participants]	25 1.6%	19 2.4%

2. Secondary Outcome

Title	All Cause Mortality
Description	All deaths, due to any cause
Time Frame	three months after myocardial infarction

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wearable Defibrillator	Conventional Treatment
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator	subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Measure Participants	1524	778
Count of Participants [Participants]	48 3.1%	38 4.9%

3. Secondary Outcome

Title	Compliance With Wearable Defibrillator Use
Description	daily wear time of the device
Time Frame	three months after myocardial infarction

Outcome Measure Data

Analysis Population Description

Conventional treatment participants did not wear defibrillator.

Arm/Group Title	Wearable Defibrillator	Conventional Treatment
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator	subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Measure Participants	1524	0
Median (Inter-Quartile Range) [hours per day]	18

Adverse Events

Time Frame	3 months
Arm/Group Title	Wearable Defibrillator		Conventional Treatment
Arm/Group Description	subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator		subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
All Cause Mortality
	Wearable Defibrillator		Conventional Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/1524 (3.1%)		38/778 (4.9%)
Serious Adverse Events
	Wearable Defibrillator		Conventional Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	475/1524 (31.2%)		253/778 (32.5%)
Cardiac disorders
CHD hospitalization, 1st event post-randomization	475/1524 (31.2%)	475	253/778 (32.5%)	253
Other (Not Including Serious) Adverse Events
	Wearable Defibrillator		Conventional Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1421/1524 (93.2%)		714/778 (91.8%)
Cardiac disorders
Palpitations	327/1524 (21.5%)		182/778 (23.4%)
Chest pain	265/1524 (17.4%)		151/778 (19.4%)
Gastrointestinal disorders
Nausea	132/1524 (8.7%)		85/778 (10.9%)
General disorders
Fatigue	510/1524 (33.5%)		274/778 (35.2%)
Trouble sleeping	551/1524 (36.2%)		264/778 (33.9%)
Dizziness	344/1524 (22.6%)		166/778 (21.3%)
Fainting	59/1524 (3.9%)		36/778 (4.6%)
Headache	259/1524 (17%)		136/778 (17.5%)
Musculoskeletal and connective tissue disorders
Back pain	283/1524 (18.6%)		137/778 (17.6%)
Respiratory, thoracic and mediastinal disorders
Shortness of breath	548/1524 (36%)		321/778 (41.3%)
Skin and subcutaneous tissue disorders
Rash in any location	216/1524 (14.2%)		50/778 (6.4%)
Rash on torso	184/1524 (12.1%)		27/778 (3.5%)
Itch in any location	243/1524 (15.9%)		45/778 (5.8%)
Itch on torso	205/1524 (13.5%)		22/778 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.