Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1800
Summary
- Conditions
- Cardiovascular Disease
- Diabetes Mellitus
- Tachycardia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
In this study, subjects will be randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization will be stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject will be dependent on the date of en...
In this study, subjects will be randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization will be stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject will be dependent on the date of entry into the study, since all subjects will be followed to a common study termination date.
Tracking Information
- NCT #
- NCT02787785
- Collaborators
- University of Rochester
- Investigators
- Principal Investigator: Valentina Kutyifa, MD, MSc, PhD University of Rochester Heart Research Follow-up Program
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