The Global cVAD Study

NCT04136392 | Unknown FDA Device

• 3 other identifiers: cVADUSPellaThe Global cVAD Registry
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 51

Brief 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 future research and regulatory filings.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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.

  January 2025

Study Arms (1)

Eligible Patients

The 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.

Device: ABIOMED, Inc. hemodynamic support devices

Interventions

ABIOMED, Inc. hemodynamic support devices DEVICE

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.

Eligible Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abiomed Inc.: lead
• Beth Israel Deaconess Medical Center: collaborator
• Yale University: collaborator

Study Sites (51)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Banner Health Research Institute, Banner Good Samaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Banner University Medical Center

Tucson, Arizona, 85724, United States

Location

University of Southern California Keck Hospital

Los Angeles, California, 90033, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

The Center for Advanced Research Excellence - Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Mercy Hospital Research Institute

Miami, Florida, 33133, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

University Cardiology Associates

Augusta, Georgia, 30901, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University of Louisville School of Medicine

Louisville, Kentucky, 40292, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Health Services Corporation

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital - Corrigan Minehan Heart Center

Boston, Massachusetts, 02114, United States

Location

St. Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Beaumont Health Center

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mercy Health Anderson

Cincinnati, Ohio, 45255, United States

Location

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45414, United States

Location

Mercy Health - Fairfield Hospital Research Center

Fairfield, Ohio, 45014, United States

Location

Integris Cardiovascular Physicians

Oklahoma City, Oklahoma, 73112, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Pinnacle Health Cardiovascular Institute Inc.

Wormleysburg, Pennsylvania, 17043, United States

Location

Jackson General Hospital

Jackson, Tennessee, 38301, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart and Vascular Institute

Dallas, Texas, 75204, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine - TX Heart Institute

Houston, Texas, 77004, United States

Location

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

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25301, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (35)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 25689546 BACKGROUND

• 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.

  PMID: 24174321 BACKGROUND

• 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.

  PMID: 20082934 BACKGROUND

• 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.

  PMID: 24329756 BACKGROUND

• 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.

  PMID: 26542494 BACKGROUND

• 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.

  PMID: 24090575 BACKGROUND

• 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.

  PMID: 15895406 BACKGROUND

• 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.

  PMID: 19941329 BACKGROUND

• 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.

  PMID: 21317769 BACKGROUND

• Meyns B, Stolinski J, Leunens V, Verbeken E, Flameng W. Left ventricular support by catheter-mounted axial flow pump reduces infarct size. J Am Coll Cardiol. 2003 Apr 2;41(7):1087-95. doi: 10.1016/s0735-1097(03)00084-6.

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• Naidu SS. Novel percutaneous cardiac assist devices: the science of and indications for hemodynamic support. Circulation. 2011 Feb 8;123(5):533-43. doi: 10.1161/CIRCULATIONAHA.110.945055. No abstract available.

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• Burkhoff D, Naidu SS. The science behind percutaneous hemodynamic support: a review and comparison of support strategies. Catheter Cardiovasc Interv. 2012 Nov 1;80(5):816-29. doi: 10.1002/ccd.24421. Epub 2012 Apr 18.

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• Remmelink M, Sjauw KD, Henriques JP, de Winter RJ, Koch KT, van der Schaaf RJ, Vis MM, Tijssen JG, Piek JJ, Baan J Jr. Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics. Catheter Cardiovasc Interv. 2007 Oct 1;70(4):532-7. doi: 10.1002/ccd.21160.

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• Cotter G, Williams SG, Vered Z, Tan LB. Role of cardiac power in heart failure. Curr Opin Cardiol. 2003 May;18(3):215-22. doi: 10.1097/00001573-200305000-00007.

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• Fincke R, Hochman JS, Lowe AM, Menon V, Slater JN, Webb JG, LeJemtel TH, Cotter G; SHOCK Investigators. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004 Jul 21;44(2):340-8. doi: 10.1016/j.jacc.2004.03.060.

  PMID: 15261929 BACKGROUND

• Torgersen C, Schmittinger CA, Wagner S, Ulmer H, Takala J, Jakob SM, Dunser MW. Hemodynamic variables and mortality in cardiogenic shock: a retrospective cohort study. Crit Care. 2009;13(5):R157. doi: 10.1186/cc8114. Epub 2009 Oct 2.

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• Mendoza DD, Cooper HA, Panza JA. Cardiac power output predicts mortality across a broad spectrum of patients with acute cardiac disease. Am Heart J. 2007 Mar;153(3):366-70. doi: 10.1016/j.ahj.2006.11.014.

  PMID: 17307413 BACKGROUND

• Sauren LD, Accord RE, Hamzeh K, de Jong M, van der Nagel T, van der Veen FH, Maessen JG. Combined Impella and intra-aortic balloon pump support to improve both ventricular unloading and coronary blood flow for myocardial recovery: an experimental study. Artif Organs. 2007 Nov;31(11):839-42. doi: 10.1111/j.1525-1594.2007.00477.x.

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• Reesink KD, Dekker AL, Van Ommen V, Soemers C, Geskes GG, van der Veen FH, Maessen JG. Miniature intracardiac assist device provides more effective cardiac unloading and circulatory support during severe left heart failure than intraaortic balloon pumping. Chest. 2004 Sep;126(3):896-902. doi: 10.1378/chest.126.3.896.

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• Henriques JP, Ouweneel DM, Naidu SS, Palacios IF, Popma J, Ohman EM, O'Neill WW. Evaluating the learning curve in the prospective Randomized Clinical Trial of hemodynamic support with Impella 2.5 versus Intra-Aortic Balloon Pump in patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the PROTECT II study. Am Heart J. 2014 Apr;167(4):472-479.e5. doi: 10.1016/j.ahj.2013.12.018. Epub 2014 Jan 3.

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• Velagapudi P, Bellumkonda L, Cohen DJ, Lansky AJ, Abu-Much A, Thompson JB, Schonning MJ, Redfors B, Zhou Z, Grines CL, Maini AS, Li Y, Batchelor WB, O'Neill WW. Clinical outcomes of aortic stenosis patients undergoing Impella-supported high-risk percutaneous coronary intervention. Front Cardiovasc Med. 2026 Jan 7;12:1638259. doi: 10.3389/fcvm.2025.1638259. eCollection 2025.

  PMID: 41573507 DERIVED

• Lemor A, Shah T, Thompson JB, Protty MB, Mamas MA, Kinnaird T, Bharadwaj AS, Truesdell AG, Schonning MJ, Zhang Y, Hussain Y, Falah B, Cohen DJ, Redfors B, Baron SJ, Witzke CF, Dixon SR, Basir MB, Lansky AJ, O'Neill WW. Novel risk score for patients undergoing Impella-assisted high-risk percutaneous coronary intervention. Cardiovasc Revasc Med. 2025 Dec;81:86-94. doi: 10.1016/j.carrev.2025.05.031. Epub 2025 May 30.

  PMID: 40541479 DERIVED

• Maini AS, Abu-Much A, Redfors B, Wollmuth JR, Basir MB, Faraz HA, Thompson JB, Schonning MJ, Falah B, Moses JW, O'Neill WW. Outcomes among patients with coronary bifurcation lesions undergoing Impella-supported high-risk percutaneous coronary intervention. Am Heart J. 2025 Dec;290:6-16. doi: 10.1016/j.ahj.2025.05.013. Epub 2025 May 22.

  PMID: 40412495 DERIVED

• Bonnet G, Rommel KP, Falah B, Lansky AJ, Zhang Y, Schonning MJ, Redfors B, Burkhoff D, Cohen DJ, Basir MB, O'Neill WW, Granada JF. Impact of Mean Blood Pressure Profiles in Percutaneous Left Ventricular Assist Device-Supported High-Risk Percutaneous Coronary Intervention: The PROTECT III Study. J Am Heart Assoc. 2025 May 20;14(10):e036367. doi: 10.1161/JAHA.124.036367. Epub 2025 May 15.

  PMID: 40371603 DERIVED

• Jakob P, Lansky AJ, Basir MB, Schonning MJ, Falah B, Zhou Z, Batchelor WB, Abu-Much A, Grines CL, O'Neill WW, Stahli BE. Characteristics and Outcomes of Older Patients Undergoing Protected Percutaneous Coronary Intervention With Impella. J Am Heart Assoc. 2025 May 6;14(9):e038509. doi: 10.1161/JAHA.124.038509. Epub 2025 Apr 16.

  PMID: 40240978 DERIVED

• Abu-Much A, Grines CL, Chen S, Batchelor WB, Zhao D, Falah B, Maini AS, Redfors B, Bellumkonda L, Bharadwaj AS, Moses JW, Truesdell AG, Zhang Y, Zhou Z, Baron SJ, Lansky AJ, Basir MB, O'Neill WW, Cohen DJ. Clinical outcomes among patients with mitral valve regurgitation undergoing Impella-supported high-risk PCI. Int J Cardiol. 2024 Dec 15;417:132555. doi: 10.1016/j.ijcard.2024.132555. Epub 2024 Sep 11.

  PMID: 39270940 DERIVED

• Falah B, Redfors B, Zhao D, Bharadwaj AS, Basir MB, Thompson JB, Patel RAG, Schonning MJ, Abu-Much A, Zhang Y, Batchelor WB, Grines CL, O'Neill WW. Implications of anemia in patients undergoing PCI with Impella-support: insights from the PROTECT III study. Front Cardiovasc Med. 2024 Jul 18;11:1429900. doi: 10.3389/fcvm.2024.1429900. eCollection 2024.

  PMID: 39091353 DERIVED

• Bharadwaj AS, Abu-Much A, Maini AS, Zhou Z, Li Y, Batchelor WB, Grines CL, Baron SJ, Redfors B, Lansky AJ, Basir MB, O'Neill WW. Angiographic Characteristics and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study. Circ Cardiovasc Interv. 2024 Jul;17(7):e013503. doi: 10.1161/CIRCINTERVENTIONS.123.013503. Epub 2024 May 6.

  PMID: 38708609 DERIVED

• Shah T, Abu-Much A, Batchelor WB, Grines CL, Baron SJ, Zhou Z, Li Y, Maini AS, Redfors B, Hussain Y, Wollmuth JR, Basir MB, O'Neill WW, Lansky AJ. Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1721-1729. doi: 10.1016/j.jcin.2023.04.036. Epub 2023 Jul 5.

  PMID: 37409991 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ali Almedhychy, MD

  Abiomed Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 23, 2019
• Study Start: July 14, 2017
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (51)