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 |
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Recruitment Status :
Completed
First Posted : August 19, 2016
Last Update Posted : October 20, 2017
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Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
- Study Details
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Severe Cardiac Insufficiency | Other: Implantable cardioverter-defibrillator |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pacemakers and Implantable Defibrillators
Intervention Details:
- Other: Implantable cardioverter-defibrillator
Collection of clinical, biological, hemodynamic and rhythmic data
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 ]
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 |
Study Population
Patient with continuous flow left ventricular assist device
Criteria
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
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
Locations
| France | |
| 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 | |
Sponsors and Collaborators
Rennes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT02873169 History of Changes |
| 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:
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Left ventricular assist device Ventricular Arrhythmias Implantable Cardioverter-defibrillator |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |