Recruiting

Observational Study

Sponsor:

QuesGen Systems Inc

Code:

NCT03604133

Conditions

Arrhythmia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Arrhythmia

Study ID

NCT03604133

Start date

Aug 24, 2017

Status verified date

Jan, 2021

Completion date

Aug 24, 2028

Anticipated

Primary completion date

Aug 24, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients receiving ICD devices

Primary outcome measure

  • Successful Implantation [ Time Frame: Two-week follow-up assessment ]

Central Contacts and Locations

Central contacts

Locations

Cardio Surgical Partners, LLC

Recruiting

Lehi, Utah, United States, 84043

Contacts

More Information

Sponsor

QuesGen Systems Inc

Last update posted

Jan 22, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by QuesGen Systems Inc on 2021-01-22.