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)

NCT ID: NCT02873169

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

681 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Cardiac Insufficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Left ventricular assist device Ventricular Arrhythmias Implantable Cardioverter-defibrillator

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantable cardioverter-defibrillator

Collection of clinical, biological, hemodynamic and rhythmic data

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Bordeaux

Bordeaux, , France

Site Status

Hospices Civils de Lyon - Hôpital Louis Pradel

Bron, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Centre chirurgical Marie-Lannelongue

Le Plessis-Robinson, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

AP-HM - Hôpital de la Timone

Marseille, , France

Site Status

CHRU de Montpellier

Montpellier, , France

Site Status

CHRU de Nancy

Nancy, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

APHP - Hôpital Bichat

Paris, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Charton M, Flecher 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, Pelce 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. No abstract available.

Reference Type DERIVED
PMID: 32153210 (View on PubMed)

Galand V, Flecher E, Auffret V, Pichard C, Boule S, Vincentelli A, Rollin A, Mondoly P, Barandon L, Pernot M, Kindo M, Cardi T, Gaudard P, Rouviere P, Senage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelce E, Gariboldi V, Pozzi M, Obadia JF, Savoure 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.

Reference Type DERIVED
PMID: 31439296 (View on PubMed)

Martins RP, Leclercq C, Bourenane H, Auffret V, Boule S, Loobuyck V, Dambrin C, Mondoly P, Sacher F, Bordachar P, Kindo M, Cardi T, Gaudard P, Rouviere P, Michel M, Gourraud JB, Defaye P, Chavanon O, Kerneis C, Ghodhbane W, Pelce 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, Flecher 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.

Reference Type DERIVED
PMID: 31255846 (View on PubMed)

Tattevin P, Flecher E, Auffret V, Leclercq C, Boule S, Vincentelli A, Dambrin C, Delmas C, Barandon L, Veniard V, Kindo M, Cardi T, Gaudard P, Rouviere P, Senage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Para M, Pelce E, Gariboldi V, Pozzi M, Grinberg D, Savoure 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.

Reference Type DERIVED
PMID: 31174053 (View on PubMed)

Galand V, Flecher E, Auffret V, Boule S, Vincentelli A, Dambrin C, Mondoly P, Sacher F, Nubret K, Kindo M, Cardi T, Gaudard P, Rouviere P, Michel M, Gourraud JB, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelce 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.

Reference Type DERIVED
PMID: 30236390 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

35RC15_8806_ASSIST-ICD

Identifier Type: -

Identifier Source: org_study_id