Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
NCT ID: NCT06690567
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
700 participants
OBSERVATIONAL
2024-10-10
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantation
Impella implantation as only intervention needed
Impella implantation
To implante Impella
Interventions
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Impella implantation
To implante Impella
Eligibility Criteria
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Inclusion Criteria
* Impella® device implanted (CP, 5, 5.5)
Exclusion Criteria
* No Impella implanted
18 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Fabrizio D'Ascenzo
Medical Doctor
Locations
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AOU Città della Salute e della Scienza di Torino
Torino, Italy, Italy
Countries
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References
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O'Neill WW, Anderson M, Burkhoff D, Grines CL, Kapur NK, Lansky AJ, Mannino S, McCabe JM, Alaswad K, Daggubati R, Wohns D, Meraj PM, Pinto DS, Popma JJ, Moses JW, Schreiber TL, Magnus Ohman E. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J. 2022 Jun;248:139-149. doi: 10.1016/j.ahj.2022.02.006. Epub 2022 Feb 19.
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.
Chieffo A, Ancona MB, Burzotta F, Pazzanese V, Briguori C, Trani C, Piva T, De Marco F, Di Biasi M, Pagnotta P, Casu G, Giustino G, Montorfano M, Pappalardo F, Tarantini G; Collaborators. Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry. EuroIntervention. 2020 Feb 7;15(15):e1343-e1350. doi: 10.4244/EIJ-D-19-00428.
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.
Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.
Geller BJ, Sinha SS, Kapur NK, Bakitas M, Balsam LB, Chikwe J, Klein DG, Kochar A, Masri SC, Sims DB, Wong GC, Katz JN, van Diepen S; American Heart Association Acute Cardiac Care and General Cardiology Committee of the Council on Clinical Cardiology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Cardiovascular Surgery and Anesthesia. Escalating and De-escalating Temporary Mechanical Circulatory Support in Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 9;146(6):e50-e68. doi: 10.1161/CIR.0000000000001076. Epub 2022 Jul 7.
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
Potapov EV, Antonides C, Crespo-Leiro MG, Combes A, Farber G, Hannan MM, Kukucka M, de Jonge N, Loforte A, Lund LH, Mohacsi P, Morshuis M, Netuka I, Ozbaran M, Pappalardo F, Scandroglio AM, Schweiger M, Tsui S, Zimpfer D, Gustafsson F. 2019 EACTS Expert Consensus on long-term mechanical circulatory support. Eur J Cardiothorac Surg. 2019 Aug 1;56(2):230-270. doi: 10.1093/ejcts/ezz098.
Lauten A, Engstrom AE, Jung C, Empen K, Erne P, Cook S, Windecker S, Bergmann MW, Klingenberg R, Luscher TF, Haude M, Rulands D, Butter C, Ullman B, Hellgren L, Modena MG, Pedrazzini G, Henriques JP, Figulla HR, Ferrari M. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013 Jan;6(1):23-30. doi: 10.1161/CIRCHEARTFAILURE.112.967224. Epub 2012 Dec 4.
Other Identifiers
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IMMMERGE
Identifier Type: -
Identifier Source: org_study_id
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