Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

NCT ID: NCT03604133

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-24

Study Completion Date

2028-08-24

Brief Summary

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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.

Detailed Description

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Conditions

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Arrhythmia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving ICD devices

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardio Surgical Partners

NETWORK

Sponsor Role collaborator

QuesGen Systems Inc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardio Surgical Partners, LLC

Lehi, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Jarrett, MBA

Role: CONTACT

415-608-3570

Martin Jorgensen, PhD

Role: CONTACT

650-777-7617

Facility Contacts

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Michael Dutton

Role: primary

801-358-4231

Other Identifiers

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2018-310 Cardiac Registry

Identifier Type: -

Identifier Source: org_study_id

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