NCT02873169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
681

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

October 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

August 16, 2016

Last Update Submit

October 19, 2017

Conditions

Severe Cardiac Insufficiency

Keywords

Left ventricular assist deviceVentricular ArrhythmiasImplantable Cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

  • Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD

    Clinical, biological, hemodynamic and rhythmic data

    30 days

Secondary Outcomes (2)

  • Mortality in patients with CF-LVAD with or without VAs

    30 days

  • Mortality in patients with CF-LVAD with or without ICD

    30 days

Interventions

Implantable cardioverter-defibrillatorOTHER

Collection of clinical, biological, hemodynamic and rhythmic data

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with continuous flow left ventricular assist device

You may qualify if:

  • Patient above 18 years old
  • Patients with CF-LVAD with or without ICD

You may not qualify if:

  • Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU de Bordeaux

Bordeaux, 33600, France

Location

Hospices Civils de Lyon - Hôpital Louis Pradel

Bron, 69677, France

Location

CHU de Caen

Caen, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38700, France

Location

Centre chirurgical Marie-Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHRU de Lille

Lille, 59037, France

Location

AP-HM - Hôpital de la Timone

Marseille, 13385, France

Location

CHRU de Montpellier

Montpellier, 34295, France

Location

CHRU de Nancy

Nancy, 54500, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

APHP - Hôpital Bichat

Paris, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

CHU de Toulouse

Toulouse, France

Location

CHRU de Tours

Tours, 37170, France

Location

Related Publications (5)

  • 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.

    PMID: 32153210DERIVED

  • 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.

    PMID: 31439296DERIVED

  • 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.

    PMID: 31255846DERIVED

  • 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.

    PMID: 31174053DERIVED

  • 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.

    PMID: 30236390DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

September 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

October 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(20)