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Cardiovascular DiseasescVADNCT04136392

The Global cVAD Study

An observational study of Cardiovascular Diseases, run by Abiomed Inc. at 51 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The intent of the Global cVAD Study is to utilize observational data of the ABIOMED, Inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a tool to measure and improve the quality of patient care and to serve as a resource for… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiovascular Diseases
What is being tested?
ABIOMED, Inc. hemodynamic support devices
Type of treatment
Medical device
How many people
20,000 participants
Where
51 sitesUnited States
Study dates
14 Jul 2017to Jan 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects who received mechanical circulatory support with an ABIOMED, Inc. hemodynamic support device per treating physician's discretion and best practices will be considered eligible for enrollment. Subjects in whom an attempt was made to implant an ABIOMED, Inc. hemodynamic support device will also be included, even though the attempt was unsuccessful. An attempt is defined as the ABIOMED, Inc. hemodynamic support catheter came in contact with the subject's skin but was not successfully placed.

Who may be able to join

  • 1. All subjects in the study population are eligible for enrollment at the time of receiving support from an ABIOMED, Inc. hemodynamic support device, or at the time of attempt to implant an ABIOMED, Inc. hemodynamic support device.

Who cannot join

  • 1. Patients in whom an attempt to implant an ABIOMED, Inc. hemodynamic support device did not occur.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • University of Michigan Cardiovascular Center

    Ann Arbor, Michigan, 48109

  • University Cardiology Associates

    Augusta, Georgia, 30901

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital - Corrigan Minehan Heart Center

    Boston, Massachusetts, 02114

  • Charleston Area Medical Center

    Charleston, West Virginia, 25301

  • Mercy Health Anderson

    Cincinnati, Ohio, 45255

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Baylor Heart and Vascular Institute

    Dallas, Texas, 75204

  • Good Samaritan Hospital

    Dayton, Ohio, 45414

  • The Center for Advanced Research Excellence - Delray Medical Center

    Delray Beach, Florida, 33484

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension St. John Hospital

    Detroit, Michigan, 48236

  • Mercy Health - Fairfield Hospital Research Center

    Fairfield, Ohio, 45014

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine - TX Heart Institute

    Houston, Texas, 77004

  • The University of Texas - Health Science Center & Medical School at Houston

    Houston, Texas, 77030

  • Jackson General Hospital

    Jackson, Tennessee, 38301

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • University of Southern California Keck Hospital

    Los Angeles, California, 90033

  • Cedars Sinai

    Los Angeles, California, 90048

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40292

  • Northwell Health

    Manhasset, New York, 11030

  • WellStar Research Institute

    Marietta, Georgia, 30060

  • Mercy Hospital Research Institute

    Miami, Florida, 33133

  • University of Miami

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Health Services Corporation

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Integris Cardiovascular Physicians

    Oklahoma City, Oklahoma, 73112

  • Orlando Health

    Orlando, Florida, 32806

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Banner Health Research Institute, Banner Good Samaritan Hospital

    Phoenix, Arizona, 85006

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23219

  • Carilion Medical Center

    Roanoke, Virginia, 24014

  • Beaumont Health Center

    Royal Oak, Michigan, 48073

  • University of Washington

    Seattle, Washington, 98195

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Banner University Medical Center

    Tucson, Arizona, 85724

  • St. Vincent Hospital

    Worcester, Massachusetts, 01608

  • Pinnacle Health Cardiovascular Institute Inc.

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

The intent of the Global cVAD Study is to utilize observational data of the ABIOMED, Inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a tool to measure and improve the quality of patient care and to serve as a resource for future research and regulatory filings.

Read the detailed description

Ongoing, observational, multicenter, records review of patients receiving the ABIOMED, Inc. hemodynamic support device(s). To collect in-hospital data, a waiver of consent and authorization will be requested to avoid significant biases in data reporting due to the extremely high mortality. To collect the post-discharge data on subjects who survive the index hospitalization, an informed consent will be obtained from those subjects or a waiver of informed consent will be used to collect data if the subject was implanted greater than a year from enrollment. Data will be collected through the review of existing medical records and subject telephone interview. Clinical follow-up as an office visit is not required for this study protocol. However, clinical follow-up and event-driven visits (e.g. re-hospitalizations) may occur as clinically warranted. At each follow-up time point, a telephone call to the subject will be attempted to obtain updated medical history and self-assessed cardiac function. In addition to the telephone call, the subject's medical records at the study site will be reviewed for cardiac-related clinic visits and/or cardiac-related re-hospitalization, including echocardiographic imaging. All data collected for this study will be reported on study specific electronic Case Report Forms (eCRFs) and entered into a controlled 21CFRPart11 compliant Electronic Data Capture (EDC) System by the designee at the participating site. Monitoring of the study data will be performed according to the study monitoring plan. Monitoring may be performed on-site or remotely and will not be conducted by anyone involved in data collection. A Clinical Events Committee (CEC) may be formed by the Sponsor. If convened, the CEC, an independent adjudication body composed of cardiologists and cardiac surgeons will adjudicate whether the site-reported adverse events and/or MACCE meet the study definitions for these events, and the relatedness of the events to the procedure and the device. A Steering Committee composed of internationally recognized investigators and experts in the field of interventional cardiology, cardiovascular surgery, cardiac electrophysiology, heart failure and mechanical circulatory support was established to provide technical and scientific oversight of the study.

Being tested
ABIOMED, Inc. hemodynamic support devices
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABIOMED, Inc. hemodynamic support devicesDevice

    ABIOMED, Inc. hemodynamic support technology are the smallest and least invasive percutaneous ventricular support blood pumps available on the market. They are routinely used in clinical practice in a variety of clinical scenarios to support patients in prophylactic or emergent settings.

Study groups in NCT04136392
Study groupRoleWhat they receive
Eligible PatientsThe population to be enrolled in this study includes patients whose intended treatment is to receive mechanical circulatory support with the ABIOMED, Inc. hemodynamic support devices per the treating physician's discretion and best practices.
Receives: Device: ABIOMED, Inc. hemodynamic support devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events

    Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events measured through site-reported events in study EDC through anticipatory primary completion date of January 2025.

    Measured: January 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start14 Jul 2017
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136392
Sponsor's protocol ID
cVAD
Other IDs
USPella, The Global cVAD Registry
Acronym
cVAD
Status last verified
May 2021
First submitted
9 Oct 2019
Last updated
10 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Seyfarth M, Sibbing D, Bauer I, Frohlich G, Bott-Flugel L, Byrne R, Dirschinger J, Kastrati A, Schomig A. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008.05.065.

    PubMed 19007597

  • Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.

    PubMed 19463408

  • O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30.

    PubMed 22935569

  • Griffith BP, Anderson MB, Samuels LE, Pae WE Jr, Naka Y, Frazier OH. The RECOVER I: a multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg. 2013 Feb;145(2):548-54. doi: 10.1016/j.jtcvs.2012.01.067. Epub 2012 Mar 9.

    PubMed 22405676

  • Anderson MB, Goldstein J, Milano C, Morris LD, Kormos RL, Bhama J, Kapur NK, Bansal A, Garcia J, Baker JN, Silvestry S, Holman WL, Douglas PS, O'Neill W. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015 Dec;34(12):1549-60. doi: 10.1016/j.healun.2015.08.018. Epub 2015 Sep 8.

    PubMed 26681124

  • Dangas GD, Kini AS, Sharma SK, Henriques JP, Claessen BE, Dixon SR, Massaro JM, Palacios I, Popma JJ, Ohman M, Stone GW, O'Neill WW. Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial). Am J Cardiol. 2014 Jan 15;113(2):222-8. doi: 10.1016/j.amjcard.2013.09.008.

    PubMed 24527505

  • Kovacic JC, Kini A, Banerjee S, Dangas G, Massaro J, Mehran R, Popma J, O'Neill WW, Sharma SK. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol. 2015 Feb;28(1):32-40. doi: 10.1111/joic.12166.

    PubMed 25689546

  • Cohen MG, Ghatak A, Kleiman NS, Naidu SS, Massaro JM, Kirtane AJ, Moses J, Magnus Ohman E, Dzavik V, Palacios IF, Heldman AW, Popma JJ, O'Neill WW. Optimizing rotational atherectomy in high-risk percutaneous coronary interventions: insights from the PROTECT IotaIota study. Catheter Cardiovasc Interv. 2014 Jun 1;83(7):1057-64. doi: 10.1002/ccd.25277. Epub 2013 Nov 18.

    PubMed 24174321

  • Sjauw KD, Konorza T, Erbel R, Danna PL, Viecca M, Minden HH, Butter C, Engstrom T, Hassager C, Machado FP, Pedrazzini G, Wagner DR, Schamberger R, Kerber S, Mathey DG, Schofer J, Engstrom AE, Henriques JP. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J Am Coll Cardiol. 2009 Dec 15;54(25):2430-4. doi: 10.1016/j.jacc.2009.09.018.

    PubMed 20082934

  • O'Neill WW, Schreiber T, Wohns DH, Rihal C, Naidu SS, Civitello AB, Dixon SR, Massaro JM, Maini B, Ohman EM. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol. 2014 Feb;27(1):1-11. doi: 10.1111/joic.12080. Epub 2013 Dec 13.

    PubMed 24329756

  • Cohen MG, Matthews R, Maini B, Dixon S, Vetrovec G, Wohns D, Palacios I, Popma J, Ohman EM, Schreiber T, O'Neill WW. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J. 2015 Nov;170(5):872-9. doi: 10.1016/j.ahj.2015.08.009. Epub 2015 Aug 15.

    PubMed 26542494

  • Lemaire A, Anderson MB, Lee LY, Scholz P, Prendergast T, Goodman A, Lozano AM, Spotnitz A, Batsides G. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. 2014 Jan;97(1):133-8. doi: 10.1016/j.athoracsur.2013.07.053. Epub 2013 Oct 1.

    PubMed 24090575

  • Valgimigli M, Steendijk P, Sianos G, Onderwater E, Serruys PW. Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous Impella Recover LP 2.5 assist device during high-risk coronary intervention. Catheter Cardiovasc Interv. 2005 Jun;65(2):263-7. doi: 10.1002/ccd.20380.

    PubMed 15895406

  • Remmelink M, Sjauw KD, Henriques JP, de Winter RJ, Vis MM, Koch KT, Paulus WJ, de Mol BA, Tijssen JG, Piek JJ, Baan J Jr. Effects of mechanical left ventricular unloading by Impella on left ventricular dynamics in high-risk and primary percutaneous coronary intervention patients. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):187-94. doi: 10.1002/ccd.22263.

    PubMed 19941329

  • Kawashima D, Gojo S, Nishimura T, Itoda Y, Kitahori K, Motomura N, Morota T, Murakami A, Takamoto S, Kyo S, Ono M. Left ventricular mechanical support with Impella provides more ventricular unloading in heart failure than extracorporeal membrane oxygenation. ASAIO J. 2011 May-Jun;57(3):169-76. doi: 10.1097/MAT.0b013e31820e121c.

    PubMed 21317769

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Abiomed Inc. at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events including Major Adverse Cardiac and Cerebrovascular Events (time frame: January 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136392, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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