An interventional study of wearable defibrillator in Myocardial Infarction, Ventricular Dysfunction and Sudden Death, sponsored by University of California, San Francisco. Completed at 71 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 2,348 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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LV ≤35% determined at the following time point:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
LifeVest wearable defibrillator
Also known as: LifeVest, wearable cardioverter-defibrillator, WCD, WD
Sudden Death Mortality
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
All Cause Mortality
All deaths, due to any cause
Time frame: three months after myocardial infarction
Compliance With Wearable Defibrillator Use
daily wear time of the device
Time frame: three months after myocardial infarction
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).
| Milestone | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| Started | 1554 | 794 |
| Completed | 1524 | 778 |
| Not completed | 30 | 16 |
| Withdrew: One site was dismissed due to irb irregularity | 30 | 16 |
| Milestone | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| 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 |
| Withdrew: Lost to follow-up | 10 | 12 |
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.
| Participants | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| Sudden Death Mortality | 25 | 19 |
All deaths, due to any cause
| Participants | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| All Cause Mortality | 48 | 38 |
daily wear time of the device
| hours per day | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| Compliance With Wearable Defibrillator Use | 18 (3.8 to 22.7) | — |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wearable Defibrillator | 48/1,524 (3.1%) | 475/1,524 (31.2%) | 1,421/1,524 (93.2%) |
| Conventional Treatment | 38/778 (4.9%) | 253/778 (32.5%) | 714/778 (91.8%) |
| Event | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| CHD hospitalization, 1st event post-randomizationCardiac disorders | 475/1524 | 253/778 |
| Event | Wearable Defibrillator | Conventional Treatment |
|---|---|---|
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 548/1524 | 321/778 |
| Trouble sleepingGeneral disorders | 551/1524 | 264/778 |
| FatigueGeneral disorders | 510/1524 | 274/778 |
| PalpitationsCardiac disorders | 327/1524 | 182/778 |
| DizzinessGeneral disorders | 344/1524 | 166/778 |
| Chest painCardiac disorders | 265/1524 | 151/778 |
| Back painMusculoskeletal and connective tissue disorders | 283/1524 | 137/778 |
| HeadacheGeneral disorders | 259/1524 | 136/778 |
| Itch in any locationSkin and subcutaneous tissue disorders | 243/1524 | 45/778 |
| Rash in any locationSkin and subcutaneous tissue disorders | 216/1524 | 50/778 |
| Age, Continuous(years) | Wearable Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| Mean | 60.9 ± 12.6 | 61.4 ± 12.4 | 61.2 ± 12.6 |
| Sex: Female, Male(Participants) | Wearable Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| Female | 413 | 195 | 608 |
| Male | 1108 | 577 | 1685 |
| Race (NIH/OMB)(Participants) | Wearable Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 25 | 12 | 37 |
| Asian | 23 | 14 | 37 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 143 | 75 | 218 |
| White | 1279 | 636 | 1915 |
| More than one race | 20 | 14 | 34 |
| Unknown or Not Reported | 33 | 27 | 60 |
| Left ventricular ejection fraction(percentage of total amount of blood) | Wearable Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| Mean | 28.2 ± 6.1 | 28.2 ± 5.8 | 28.2 ± 6.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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