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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

NCT02787785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-22

Study results available
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Summary

The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years.

Conditions

Interventions

DEVICE

Subcutaneous Implantable Cardioverter Defibrillator

The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Valentina Kutyifa, MD, MSc, PhD · University of Rochester Heart Research Follow-up Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787785 on ClinicalTrials.gov