- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04136392
Den globale cVAD-undersøgelse (cVAD)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85006
- Banner Health Research Institute, Banner Good Samaritan Hospital
-
Tucson, Arizona, Forenede Stater, 85724
- Banner University Medical Center
-
-
California
-
Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai
-
Los Angeles, California, Forenede Stater, 90033
- University of Southern California Keck Hospital
-
Newport Beach, California, Forenede Stater, 92663
- Hoag Memorial Hospital Presbyterian
-
-
Florida
-
Delray Beach, Florida, Forenede Stater, 33484
- The Center for Advanced Research Excellence - Delray Medical Center
-
Jacksonville, Florida, Forenede Stater, 32204
- St. Vincent's Medical Center
-
Miami, Florida, Forenede Stater, 33136
- University of Miami
-
Miami, Florida, Forenede Stater, 33133
- Mercy Hospital Research Institute
-
Orlando, Florida, Forenede Stater, 32806
- Orlando Health
-
-
Georgia
-
Augusta, Georgia, Forenede Stater, 30901
- University Cardiology Associates
-
Marietta, Georgia, Forenede Stater, 30060
- Wellstar Research Institute
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Hospital
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40292
- University of Louisville School of Medicine
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University Medical Center
-
New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Clinic Health Services Corporation
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital - Corrigan Minehan Heart Center
-
Worcester, Massachusetts, Forenede Stater, 01608
- St. Vincent Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Cardiovascular Center
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forenede Stater, 48236
- Ascension St. John Hospital
-
Detroit, Michigan, Forenede Stater, 48201
- Detroit Medical Center
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health
-
Royal Oak, Michigan, Forenede Stater, 48073
- Beaumont Health Center
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- St. Luke's Hospital
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
-
-
New York
-
Manhasset, New York, Forenede Stater, 11030
- Northwell Health
-
Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital
-
New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mt. Sinai
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45255
- Mercy Health Anderson
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospital Cleveland Medical Center
-
Dayton, Ohio, Forenede Stater, 45414
- Good Samaritan Hospital
-
Fairfield, Ohio, Forenede Stater, 45014
- Mercy Health - Fairfield Hospital Research Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73112
- INTEGRIS Cardiovascular Physicians
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Medical Center
-
Wormleysburg, Pennsylvania, Forenede Stater, 17043
- Pinnacle Health Cardiovascular Institute Inc.
-
-
Tennessee
-
Jackson, Tennessee, Forenede Stater, 38301
- Jackson General Hospital
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75204
- Baylor Heart and Vascular Institute
-
Fort Worth, Texas, Forenede Stater, 76104
- Plaza Medical Center of Fort Worth
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas - Health Science Center & Medical School at Houston
-
Houston, Texas, Forenede Stater, 77004
- Baylor College of Medicine - TX Heart Institute
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23219
- Virginia Commonwealth University Health System
-
Roanoke, Virginia, Forenede Stater, 24014
- Carilion Medical Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25301
- Charleston Area Medical Center
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
1. Alle forsøgspersoner i undersøgelsespopulationen er berettiget til tilmelding på tidspunktet for modtagelse af støtte fra en ABIOMED, Inc. hæmodynamisk støtteanordning eller på tidspunktet for forsøg på at implantere en ABIOMED, Inc. hæmodynamisk støtteanordning.
Ekskluderingskriterier:
1. Patienter, hvor et forsøg på at implantere en ABIOMED, Inc. hæmodynamisk støtteanordning ikke fandt sted.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Berettigede patienter
Populationen, der skal tilmeldes denne undersøgelse, omfatter patienter, hvis påtænkte behandling er at modtage mekanisk kredsløbsstøtte med ABIOMED, Inc. hæmodynamiske støtteanordninger efter den behandlende læges skøn og bedste praksis.
|
ABIOMED, Inc. hæmodynamiske støtteteknologi er de mindste og mindst invasive perkutane ventrikulære støtteblodpumper på markedet.
De bruges rutinemæssigt i klinisk praksis i en række forskellige kliniske scenarier for at støtte patienter i profylaktiske eller akutte situationer.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af uønskede hændelser, herunder større uønskede hjerte- og cerebrovaskulære hændelser
Tidsramme: Januar 2025
|
Hyppigheden af uønskede hændelser inklusive større uønskede hjerte- og cerebrovaskulære hændelser målt gennem sted-rapporterede hændelser i undersøgelse EDC til den forventede primære afslutningsdato i januar 2025.
|
Januar 2025
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Ali Almedhychy, MD, Abiomed Inc.
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- cVAD
- USPella (Anden identifikator: Abiomed, Inc.)
- The Global cVAD Registry (Anden identifikator: Abiomed, Inc.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hjerte-kar-sygdomme
-
Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada