NCT03604133

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Aug 2017Aug 2028

Study Start

First participant enrolled

August 24, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2028

Expected
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6 years

First QC Date

July 18, 2018

Last Update Submit

January 20, 2021

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Successful Implantation

    Patient undergoes surgery for ICD device implantation

    Two-week follow-up assessment

Study Arms (1)

Patients receiving ICD devices

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who require ICD to maintain optimal health.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardio Surgical Partners, LLC

Lehi, Utah, 84043, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Jarrett, MBA

CONTACT

415-608-3570mike.jarrett@quesgen.com

Martin Jorgensen, PhD

CONTACT

650-777-7617martin.jorgensen@quesgen.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 27, 2018

Study Start

August 24, 2017

Primary Completion

August 24, 2023

Study Completion (Estimated)

August 24, 2028

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

US(1)