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Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry

NCT01085435 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 994

Last updated 2025-05-20

Study results available
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Summary

The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

Conditions

  • Tachycardia, Ventricular

Interventions

DEVICE

S-ICD System

The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Pier Lambiase, Prof. · St. Bartholomew's Hospital, London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-02
Primary Completion
2020-02-29
Completion
2024-01-31
FDA Device
Yes

Countries

  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Portugal
  • Spain
  • 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 NCT01085435 on ClinicalTrials.gov