- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894580
Primary Prevention of Sudden Cardiac Death (PREV-DEATH) (PREV-DEATH)
Primary Prevention of Sudden Cardiac Death in Real Life: Differences With the Pivotal Studies and Their Consequences
Study Overview
Status
Conditions
Detailed Description
The clinical efficacy of implantable cardioverter defibrillator (ICD) as method of primary prevention of sudden cardiac death (SCD) is well demonstrated today. Unfortunately, selection criteria of patients deemed at risk lacks of specificity. For asymptomatic patients with a left ventricular dysfunction (LVEF), current guidelines support implantation of ICD if the LVEF is ≤35%. This target population corresponds to the one studied in the Sudden Cardiac Death in HEart Failure Trial (SCD-HeFT). This trial is 10 years old. The proportion of patients with LVEF > 30% was low (17%) and the analysis of this subgroup showed no decrease in mortality (hazard ratio = 1.08 [0.57-2.07]). That is why the usefulness of ICD in this segment of the population remains a subject of controversy. Moreover, SCD-HeFT did not offer resynchronization therapy despite the fact that more than 40% of patients included had a QRS signal duration ≥120ms.
Conditions for implantation have since changed considerably. The "routine" nature of the implantation procedure and the desire to maximize patient's protection leads us to address for an implantation more easily. As for the resynchronization, it must be attempted in patients with severe heart failure, LVEF ≤35% and QRS sufficiently prolonged.
This suggests that the implanted population is very different nowadays from those from the pivotal studies in terms of mean LVEF and implanted material. However, these two factors are significantly correlated with the risk of SCD... Therefore, the analysis was done on samples of patients who received ICD in primary prevention setting. This study focused on the effect of resynchronization and LVEF at implantation and the subsequent outcome. The results were broadly compared with those of SCD-HeFT.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Metz Cedex 03, France, 57085
- CHR Metz-Thionville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- primo-implantation and primary prevention in New York Heart Association (NYHA) II or III chronic heart failure due to ischemic or non ischemic causes and LVEF ≤35%
Exclusion Criteria:
- Cardiomyopathy other than dilated cardiomyopathy such as hypertrophic cardiomyopathy, congenital or valvular heart disease
- Patients with NYHA class I and IV heart failure
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mortality from any cause
Time Frame: up to 1 year
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up to 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Michel BOUSIER, MD, CHR Metz-Thionville
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-04Obs-CHRMT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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