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Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • N/A

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients receiving ICD devices

Recruiting Locations

Cardio Surgical Partners, LLC
Lehi 5777224, Utah 5549030 84043
Contact:
Michael Dutton
801-358-4231
mdutton@cardiosp.com

More Details

Status
Recruiting
Sponsor
QuesGen Systems Inc

Study Contact

Michael Jarrett, MBA
415-608-3570
mike.jarrett@quesgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.