NCT02787785

Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, subjects were randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization was stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject was dependent on the date of entry into the study, since all subjects were followed to a common study termination date.

Conditions

• Tachycardia
• Diabetes Mellitus
• Cardiovascular Disease

Interventions

Type	Name	Description
DEVICE	Subcutaneous Implantable Cardioverter Defibrillator	The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Timeline

• Start date: 2017-04-17
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2016-06-01
• Last updated: 2024-08-22
• Results posted: 2024-08-22

Locations

49 sites across 7 countries: United States, Germany, Israel, Italy, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated device study