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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

Tracking Information
First Submitted Date August 16, 2016
First Posted Date August 19, 2016
Last Update Posted Date October 20, 2017
Study Start Date September 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 18, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
Official Title Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient with continuous flow left ventricular assist device
Condition Severe Cardiac Insufficiency
Intervention Other: Implantable cardioverter-defibrillator
Collection of clinical, biological, hemodynamic and rhythmic data
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 19, 2017)
681
Original Estimated Enrollment
 (submitted: August 18, 2016)
500
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02873169
Other Study ID Numbers 35RC15_8806_ASSIST-ICD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor Rennes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Rennes University Hospital
Verification Date February 2017