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A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy

NCT01296022 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2023-05-09

No results posted yet for this study

Summary

This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

Conditions

  • Ventricular Arrhythmias

Interventions

DEVICE

Implantation of subcutaneous ICD

Implantation of subcutaneous ICD

DEVICE

Implantation of transvenous ICD

Implantation of transvenous ICD

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Reinoud E Knops, MD, PhD · Academic Medical Center - University of Amsterdam (AMC-UvA)

  • Arthur A.M. Wilde, MD, PhD · Academic Medical Center - University of Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2019-12-31
Completion
2023-12-31

Countries

  • United States
  • Czechia
  • Denmark
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT01296022 on ClinicalTrials.gov