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Clinical Trials/NCT03604133
NCT03604133
Recruiting
Not Applicable

Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

QuesGen Systems Inc1 site in 1 country500 target enrollmentAugust 24, 2017
ConditionsArrhythmia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia
Sponsor
QuesGen Systems Inc
Enrollment
500
Locations
1
Primary Endpoint
Successful Implantation
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.

Registry
clinicaltrials.gov
Start Date
August 24, 2017
End Date
August 24, 2028
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Successful Implantation

Time Frame: Two-week follow-up assessment

Patient undergoes surgery for ICD device implantation

Study Sites (1)

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