Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03604133

Acronym

ASC ICD Reg

Enrollment

500

Registered

2018-07-27

Start date

2017-08-24

Completion date

2028-08-24

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Successful Implantation	Two-week follow-up assessment	Patient undergoes surgery for ICD device implantation

Countries

United States

Contacts

Primary ContactMichael Jarrett, MBA

mike.jarrett@quesgen.com415-608-3570

Backup ContactMartin Jorgensen, PhD

martin.jorgensen@quesgen.com650-777-7617

Outcome results