Vest Prevention of Early Sudden Death Trial and VEST Registry
This study is currently recruiting participants.
Verified April 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01446965
First received: October 3, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Ventricular Dysfunction Sudden Death Ventricular Tachycardia Ventricular Fibrillation |
Device: wearable defibrillator |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Sudden death mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
- incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
- adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: Yes ]
- compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1900 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Wearable defibrillator
subjects will use a wearable defibrillator for three months following myocardial infarction
|
Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
|
| No Intervention: Conventional treatment |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
- If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965
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Contacts
| Contact: Carol Maguire, RN | 415-476-5148 | cmaguire@medicine.ucsf.edu |
Hide Study LocationsLocations
| United States, Alaska | |
| Alaska Heart Institute | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Contact: Lori Heaney 907-550-2283 lheaney@alaskaheart.com | |
| Contact: Deidre Rambur 907-561-3211 drambur@alaskaheart.com | |
| Principal Investigator: Steve Compton, MD | |
| United States, California | |
| Cardiovascular Consultants Heart Center | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Tonya Reavis 559-432-4303 ext 7229 tonya.reavis@cvchc.com | |
| Principal Investigator: Michael Gen, MD | |
| Salinas Valley Memorial Healthcare System | Recruiting |
| Salinas, California, United States, 93901 | |
| Contact: Terri Nielsen 831-759-1838 tnielsen2@svmh.com | |
| Principal Investigator: Harlan Grogin, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Kourtney Imburgia 415-502-0938 kimburgia@medicine.ucsf.edu | |
| Principal Investigator: Greg Marcus, MD | |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Heather Maurer 303-724-6473 HEATHER.MAURER@UCDENVER.EDU | |
| Contact: Christina Schmitt 303-724-2098 Christina.Schmitt@ucdenver.edu | |
| Principal Investigator: William Sauer, MD | |
| United States, Connecticut | |
| Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 06102 | |
| Contact: Arben Ademi 860-545-3561 Aademi@harthosp.org | |
| Principal Investigator: Steven L Zweibel, MD | |
| United States, Delaware | |
| Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19718 | |
| Contact: Catherine Wade 302-733-2658 CaWade@Christianacare.org | |
| Principal Investigator: Michael E Stillabower, MD | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainsville, Florida, United States, 32610 | |
| Contact: Tempa Curry 352-273-8937 tempa.curry@medicine.ufl.edu | |
| Principal Investigator: William Miles, MD | |
| Watson Clinic for Research, Inc. | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| Contact: Noreen McGowan 866-688-6826 NMcgowan@watsonclinic.com | |
| Principal Investigator: Neal G Kavesh, MD | |
| Melbourne Cardiac Resarch Institute | Recruiting |
| Melbourne, Florida, United States, 32901 | |
| Contact: Mary Sochaki, 32901 321-821-4969 msochackimcri@gmail.com | |
| Principal Investigator: Rajiv Chandra, MD | |
| Florida Heart Group/Florida Hospital | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Delores Barnes 407-303-5600 ext 1102018 delores.b.barnes@flhosp.org | |
| Principal Investigator: George Monir, MD | |
| United States, Illinois | |
| Advocate Christ Hospital | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Diane Braun 708-684-4209 diane.braun@advocatehealth.com | |
| Principal Investigator: Manoj Duggal, MD | |
| Lutheran General | Suspended |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Indiana | |
| The Heart Group/Deaconess Hospital | Recruiting |
| Evansville, Indiana, United States, 47713 | |
| Contact: Amanda Johnson, CNA 812-490-4505 amanda.jonson@deaconess.com | |
| Contact: Melissa Hansen (812) 490-4507 melissa.hansen@deaconess.com | |
| Principal Investigator: Chandrashekar Kumbar, MD | |
| United States, Kentucky | |
| Western Kentucky Heart and Lung | Recruiting |
| Bowling Green, Kentucky, United States, 42101 | |
| Contact: Beau Wilkins 270-779-3957 beau.wilkins@topper.wku.edu | |
| Contact: Shirley Powell 270-782-0151 ext 103 ep.heartandlung@insightbb.com | |
| Principal Investigator: Frank Schwender, MD | |
| University of Kentucky Gill Heart Institute | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Mandy Hatfield 859-323-1082 mandy.hatfield@uky.edu | |
| Principal Investigator: Samy-Claude Elayi, MD | |
| United States, Louisiana | |
| Ochsner Clinic | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Cristine Hardy 504-842-6832 chardy@ochsner.org | |
| Contact mlunn@ochsner.org | |
| Principal Investigator: Daniel Morin, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Deborah Manuelian 617-732-5087 DMANUELIAN@PARTNERS.ORG | |
| Principal Investigator: Bruce Koplan, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Amanda M Anderson 617-643-2887 aanderson11@partners.org | |
| Principal Investigator: Theofanie Mela, MD | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Melanie Marshall 617-636-5938 mmarshall@tuftsmedicalcenter.org | |
| Contact: Laurie Butts 617-636-5938 Lbutts@tuftsmedicalcenter.org | |
| Principal Investigator: Jonathan Weinstock, MD | |
| University of Massachusetts Memorial | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Kaethe Giaquinto 508-856-2376 kaethe.Giaquinto@umassmed.edu | |
| Contact: Anjali Ryzewicz (508) 856-5143 Anjali.Ryzewicz@umassmed.edu | |
| Principal Investigator: Lawrence Rosenthal, MD | |
| United States, New Jersey | |
| The Valley Hospital | Recruiting |
| Ridgewood, New Jersey, United States, 07450 | |
| Contact: Kimberly Michel 201-447-8000 ext 2745 kmichel@valleyhealth.com | |
| Principal Investigator: Gerald Sotsky, MD | |
| United States, New Mexico | |
| Presbyterian Heart Group | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Rae Woods 505-563-2716 rwoods@phs.org | |
| Contact: Susan Salazar 505-563-2716 ssalazar2@phs.org | |
| Principal Investigator: Lawrence Nair, MD | |
| United States, New York | |
| Albany Associates in Cardiology | Recruiting |
| Albany, New York, United States, 12205 | |
| Contact: Amy Sheldon 518-435-2758 Amy.Sheldon@primecarepc.com | |
| Contact: Tabitha Harting (518)435-2759 Tabitha.Harting@primecarepc.com | |
| Principal Investigator: Robert S. Phang, MD | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Dalena Hervias 718-920-5733 dahervia@montefiore.org | |
| Principal Investigator: Jay Gross, MD | |
| United Health Services | Recruiting |
| Johnson City, New York, United States, 13790 | |
| Contact: Terri Peters, RN, MSN 607-763-5697 Terri_Peters@uhs.org | |
| Contact: Kathy Hughes 607-763-5483 Kathy_huges@uhs.org | |
| Principal Investigator: Nicohlas Stamato, MD | |
| Long Island Jewish Hospital | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Marisa Kavanaugh-Hogans 718-470-4257 Mkavanaugh@NSHS.edu | |
| Principal Investigator: David Slotwiner, MD | |
| Huntington Hospital | Recruiting |
| New York, New York, United States, 11743 | |
| Contact: Dana Kuziw 631-547-7191 dkuziw@hunthosp.org | |
| Principal Investigator: Paul Maccaro, MD | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Nicole Rothman 212-241-8353 nicole.rothman@mountsinai.org | |
| Principal Investigator: Nicholas Skipitaris, MD | |
| Lenox Hill Hospital | Recruiting |
| New York City, New York, United States, 10075 | |
| Contact: Mariamne Reyna 212-434-3362 mreyna@lenoxhill.net | |
| Principal Investigator: Ranjit Suri, MD | |
| University Cardiovascular Associates (Rochester) | Recruiting |
| Rochester, New York, United States, 14626 | |
| Contact: Kerry Estes 585-239-7334 Kerry_estes@ucva.com | |
| Principal Investigator: Sarah Taylor, MD | |
| Stony Brook University | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Jennifer Intravaia, RN, CCRC 631-444-3626 Jennifer.Intravaia@sbumed.org | |
| Contact: Michelle Yeung 631-444-8475 Michelle.Yeung2@stonybrookmedicine.edu | |
| Principal Investigator: Eric Rashba, MD | |
| United States, North Carolina | |
| University of North Carolina @ Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Cassandra Ramm 919-843-1610 cassandra_ramm@med.unc.edu | |
| Principal Investigator: Paul Mounsey, MD | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Anthony Waldron, Jr 919-681-9772 anthony.waldronjr@duke.edu | |
| Contact: Deborah Hickey 919-668-3524 deborah.hickey@duke.edu | |
| Principal Investigator: Donald Hegland, MD | |
| Wake Forest University Health Sciences | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| Contact: Nancy Sherrill 336-716-4667 nsherril@wfubmc.edu | |
| Principal Investigator: Tony W. Simmons, MD | |
| United States, Ohio | |
| University Hospital Case Medical Center | Recruiting |
| Columbus, Ohio, United States, 44106 | |
| Contact: Maria Scheutzow 216-286-6550 Maria.Scheutzow@UHhospitals.org | |
| Principal Investigator: Robert Goldstein, MD | |
| North Ohio Heart Center-North Ohio Research | Recruiting |
| Elyria, Ohio, United States, 44035 | |
| Contact: Darlene Carr 440-366-2264 dcarr@nohc.com | |
| Principal Investigator: Kara Quan, MD | |
| Cardiovascular Research Center, LLC/Mercy St Vincent | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Julie Neidhardt 419-251-4919 Julie_Neidhardt@mhsnr.org | |
| Contact: Michelle Hickam 419-251-4919 michelle_hickam@mhsnr.org | |
| Principal Investigator: Ameer Kabour, MD | |
| United States, Oklahoma | |
| Oklahoma Heart Institute-Hillcrest | Recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| Contact: Jennifer Seader 918-579-5865 JSeader@hillcrest.com | |
| Contact: Jolene Durham 918-579-4939 jdurham@hillcrest.com | |
| Principal Investigator: David A. Sandler, MD | |
| United States, Oregon | |
| Oregon Heart & Vascular | Recruiting |
| Springfield, Oregon, United States, 97477 | |
| Contact: Gayle Buie 541-222-2889 NBuie@peacehealth.org | |
| Contact: Becky Hammerschmith 541-510-9308 bhammerschmith@peacehealth.org | |
| Principal Investigator: Ramakota Reddy, MD | |
| United States, Pennsylvania | |
| Chambersburg Hospital | Recruiting |
| Chambersburg, Pennsylvania, United States, 17201 | |
| Contact: Cindy Green 717-267-4880 cgreen@summithealth.org | |
| Contact: Jacklyn Newell 717-262-4697 JNEWELL@summithealth.org | |
| Principal Investigator: Aylmer Tang, MD | |
| Geisinger Heart Institute | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Lori Scalzo 570-808-6382 lmscalzo1@geisinger.edu | |
| Contact: Jeff Ruhl 570.271.7176 jaruhl@geisinger.edu | |
| Principal Investigator: Gopi Dandamudi, MD | |
| United States, Rhode Island | |
| Brown Medical School-Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Mary Grogan 401-444-9828 mgogan@lifespan.org | |
| Principal Investigator: Peem Lorvidhaya, MD | |
| United States, South Carolina | |
| Providence/South Carolina Heart Center | Recruiting |
| Columbia, South Carolina, United States, 29204 | |
| Contact: Kelly Crump, RN 803-255-2927 Kcrump@scheart.com | |
| Principal Investigator: Venkateshwar Gottipaty, MD | |
| McLeod Health/Pee Dee Cardiology | Recruiting |
| Florence, South Carolina, United States, 29506 | |
| Contact: Rhonda Johnson 843-667-1891 ext 8465 rjohnson@mcleodhealth.org | |
| Principal Investigator: Rajesh Malik, MD | |
| United States, Tennessee | |
| Wellmont Holston Valley | Recruiting |
| Kingsport, Tennessee, United States, 37660 | |
| Contact: Ashley Sparks, LVN, CRC 423-230-5062 asparks@mycva.com | |
| Principal Investigator: Gregory Jones, MD | |
| Turkey Creek Medical Center | Recruiting |
| Knoxville, Tennessee, United States, 37934 | |
| Contact: Nancy Bradley, RN, CRC 865-218-7538 nancy.bradley@hma.com | |
| Contact: Beth Polk, RN, CCRC 865-218-7535 beth.polk@hma.com | |
| Principal Investigator: Malcolm Foster, MD | |
| United States, Texas | |
| Baylor University Medical Center | Recruiting |
| Dallas, Texas, United States, 75226 | |
| Contact: Jenny Cruthis 214-820-3319 jenncru@baylorhealth.edu | |
| Principal Investigator: Jay Franklin, MD | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Dana Red 214-590-5015 dana.red@utsouthwestern.edu | |
| Principal Investigator: Richard Wu, MD | |
| United States, Virginia | |
| Carilion Clinic | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
| Contact: Karen Buchanan, BSN, RN 540-981-7493 kdbuchanan@carilionclinic.org | |
| Contact: Amanda VanLaeken 540-853-0460 ahvanlaeken@carilionclinic.org | |
| Principal Investigator: Soufian Almahameed, MD | |
| United States, Washington | |
| Cardiac Study Center | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Kathy Marks 253-572-7320 ext 3030 kathymarks@cardiacstudycenter.com | |
| Contact: Alison Swarens 253-403-1707 Alison.Swarens@multicare.org | |
| Principal Investigator: Tariq Salam, MD | |
| Germany | |
| Universität Heidelberg | Recruiting |
| Heidelberg, Deutschland, Germany, 69120 | |
| Contact: Sonja Tran 49062115637124 sonja.tran@med.uni-heidelberg.de | |
| Principal Investigator: Dierk Thomas, MD | |
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 |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01446965 History of Changes |
| Obsolete Identifiers: | NCT00628966 |
| Other Study ID Numbers: | 90D0114 |
| Study First Received: | October 3, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Death Death, Sudden Infarction Myocardial Infarction Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Ventricular Dysfunction |
Pathologic Processes Ischemia Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arrhythmias, Cardiac |
ClinicalTrials.gov processed this record on May 23, 2013