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S-ICD® System Post Approval Study

NCT01736618 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1766

Last updated 2024-03-18

Study results available
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Summary

The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.

Conditions

  • Primary Prevention of Sudden Cardiac Arrest
  • Secondary Prevention of Sudden Cardiac Arrest

Interventions

DEVICE

S-ICD System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Maria Macuare-Gorden, MD · Boston Scientific Corporation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-12
Primary Completion
2021-10-15
Completion
2021-10-15
FDA Device
Yes

Countries

  • United States

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 NCT01736618 on ClinicalTrials.gov