Trial record 1 of 1 for:
NCT02873169
Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD) (ASSIST-ICD)
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ClinicalTrials.gov Identifier: NCT02873169
Recruitment Status :
Completed
First Posted : August 19, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
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Brief Summary:
Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.
Severe Cardiac Insufficiency
Other: Implantable cardioverter-defibrillator
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Study Type :
Observational
Actual
Enrollment :
681 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)
Study Start Date :
September 2015
Actual Primary Completion Date :
December 31, 2016
Actual Study Completion Date :
December 31, 2016
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Primary Outcome Measures :
Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD [ Time Frame: 30 days ]Clinical, biological, hemodynamic and rhythmic data
Secondary Outcome Measures :
Mortality in patients with CF-LVAD with or without VAs [ Time Frame: 30 days ]
Mortality in patients with CF-LVAD with or without ICD [ Time Frame: 30 days ]
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Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Sampling Method:
Probability Sample
Patient with continuous flow left ventricular assist device
Inclusion Criteria:
Patient above 18 years old
Patients with CF-LVAD with or without ICD
Exclusion Criteria:
Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873169
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CHU de Bordeaux
Bordeaux, France, 33600
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, France, 69677
CHU de Caen
Caen, France
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
Hôpital Henri Mondor
Créteil, France, 94010
CHU de Dijon
Dijon, France, 21079
CHU de Grenoble
Grenoble, France, 38700
Centre chirurgical Marie-Lannelongue
Le Plessis-Robinson, France, 92350
CHRU de Lille
Lille, France, 59037
AP-HM - Hôpital de la Timone
Marseille, France, 13385
CHRU de Montpellier
Montpellier, France, 34295
CHRU de Nancy
Nancy, France, 54500
CHU de Nantes
Nantes, France, 44000
Hôpital Européen Georges Pompidou
Paris, France, 75015
APHP - Hôpital Bichat
Paris, France
CHU de Rennes
Rennes, France, 35033
CHU de Rouen
Rouen, France, 76000
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
CHU de Toulouse
Toulouse, France
CHRU de Tours
Tours, France, 37170
Rennes University Hospital
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Charton M, Flécher E, Leclercq C, Delmas C, Dambrin C, Goeminne C, Vincentelli A, Michel M, Lehelias L, Verdonk C, Para M, Pozzi M, Obadia JF, Boignard A, Chavanon O, Barandon L, Nubret K, Kindo M, Minh TH, Gaudard P, Pelcé E, Gariboldi V, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bourguignon T, Genet T, Eschalier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Blangy H, Doucerain J, Martins RP, Galand V. Suicide Attempts Among LVAD Recipients: Real-Life Data From the ASSIST-ICD Study. Circulation. 2020 Mar 17;141(11):934-936. doi: 10.1161/CIRCULATIONAHA.119.041910. Epub 2020 Mar 10.
Galand V, Flécher E, Auffret V, Pichard C, Boulé S, Vincentelli A, Rollin A, Mondoly P, Barandon L, Pernot M, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Savouré A, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP. Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality. JACC Clin Electrophysiol. 2019 Aug;5(8):944-954. doi: 10.1016/j.jacep.2019.05.025. Epub 2019 Aug 19.
Martins RP, Leclercq C, Bourenane H, Auffret V, Boulé S, Loobuyck V, Dambrin C, Mondoly P, Sacher F, Bordachar P, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Kerneis C, Ghodhbane W, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschallier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Sadoul N, Flécher E, Galand V. Incidence, predictors, and clinical impact of electrical storm in patients with left ventricular assist devices: New insights from the ASSIST-ICD study. Heart Rhythm. 2019 Oct;16(10):1506-1512. doi: 10.1016/j.hrthm.2019.06.021. Epub 2019 Jun 27.
Tattevin P, Flécher E, Auffret V, Leclercq C, Boulé S, Vincentelli A, Dambrin C, Delmas C, Barandon L, Veniard V, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Para M, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Savouré A, Litzler PY, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bernard L, Bourguignon T, Eschalier R, D'Ostrevy N, Jouan J, Varlet E, Vanhuyse F, Blangy H, Martins RP, Galand V. Risk factors and prognostic impact of left ventricular assist device-associated infections. Am Heart J. 2019 Aug;214:69-76. doi: 10.1016/j.ahj.2019.04.021. Epub 2019 May 6.
Galand V, Flécher E, Auffret V, Boulé S, Vincentelli A, Dambrin C, Mondoly P, Sacher F, Nubret K, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Radu C, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP; ASSIST-ICD Investigators. Predictors and Clinical Impact of Late Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices. JACC Clin Electrophysiol. 2018 Sep;4(9):1166-1175. doi: 10.1016/j.jacep.2018.05.006. Epub 2018 Jul 25.
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Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02873169
Other Study ID Numbers:
35RC15_8806_ASSIST-ICD
First Posted:
August 19, 2016
Key Record Dates
Last Update Posted:
October 20, 2017
Last Verified:
February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
Keywords provided by Rennes University Hospital:
Left ventricular assist device
Ventricular Arrhythmias
Implantable Cardioverter-defibrillator
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases