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Severe Cardiac InsufficiencyASSIST-ICDNCT02873169

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)

An observational study of Severe Cardiac Insufficiency, run by Rennes University Hospital at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Cardiac Insufficiency
What is being tested?
Implantable cardioverter-defibrillator
How many people
681 participants
Where
20 sitesFrance
Study dates
Sep 2015to 31 Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with continuous flow left ventricular assist device

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHU de Bordeaux

    Bordeaux, 33600

  • Hospices Civils de Lyon - Hôpital Louis Pradel

    Bron, 69677

  • CHU de Caen

    Caen

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21079

  • CHU de Grenoble

    Grenoble, 38700

  • Centre chirurgical Marie-Lannelongue

    Le Plessis-Robinson, 92350

  • CHRU de Lille

    Lille, 59037

  • AP-HM - Hôpital de la Timone

    Marseille, 13385

  • CHRU de Montpellier

    Montpellier, 34295

  • CHRU de Nancy

    Nancy, 54500

  • CHU de Nantes

    Nantes, 44000

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • APHP - Hôpital Bichat

    Paris

  • CHU de Rennes

    Rennes, 35033

  • CHU de Rouen

    Rouen, 76000

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • CHU de Toulouse

    Toulouse

  • CHRU de Tours

    Tours, 37170

Other trials in France

About this study

Official title: Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

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.

Being tested
Implantable cardioverter-defibrillator
Keywords
Left ventricular assist device, Ventricular Arrhythmias, Implantable Cardioverter-defibrillator
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable cardioverter-defibrillatorOther

    Collection of clinical, biological, hemodynamic and rhythmic data

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Secondary outcomes (2)

  1. Mortality in patients with CF-LVAD with or without VAs

    Measured: 30 days

  2. Mortality in patients with CF-LVAD with or without ICD

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873169
Sponsor's protocol ID
35RC15_8806_ASSIST-ICD
Acronym
ASSIST-ICD
Status last verified
Feb 2017
First submitted
16 Aug 2016
Last updated
20 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Beneyto M, Martins R, Galand V, Kindo M, Schneider C, Sebestyen A, Boignard A, Sebbag L, Pozzi M, Genet T, Bourguignon T, Martin AC, Achouh P, Vanhuyse F, Blang H, David CH, Michel M, Anselme F, Litzler PY, Jungling M, Vincentelli A, Eschalier R, D'Ostrevy N, Nataf P, Para M, Garnier F, Rajinthan P, Porterie J, Faure M, Picard F, Gaudard P, Rouviere P, Babatasi G, Blanchart K, Gariboldi V, Porto A, Flecher E, Delmas C. Right Ventriculoarterial Coupling Surrogates and Long-Term Survival in LVAD Recipients: Results of the ASSIST-ICD Multicentric Registry. J Card Fail. 2025 Feb;31(2):388-396. doi: 10.1016/j.cardfail.2024.05.007. Epub 2024 Jun 6.

    PubMed 38851449

  • 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.

    PubMed 32153210

  • 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.

    PubMed 31439296

  • 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.

    PubMed 31255846

  • 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.

    PubMed 31174053

  • 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.

    PubMed 30236390

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Cardiac Insufficiency, run by Rennes University Hospital at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873169, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.

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