This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry (ASC ICD Reg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604133
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Cardio Surgical Partners
Information provided by (Responsible Party):
QuesGen Systems Inc

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Arrhythmia

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : August 24, 2023
Estimated Study Completion Date : August 24, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Patients receiving ICD devices


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Successful Implantation [ Time Frame: Two-week follow-up assessment ]
    Patient undergoes surgery for ICD device implantation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who require ICD to maintain optimal health.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604133


Contacts
Layout table for location contacts
Contact: Michael Jarrett, MBA 415-608-3570 mike.jarrett@quesgen.com
Contact: Martin Jorgensen, PhD 650-777-7617 martin.jorgensen@quesgen.com

Locations
Layout table for location information
United States, Utah
Cardio Surgical Partners, LLC Recruiting
Lehi, Utah, United States, 84043
Contact: Michael Dutton    801-358-4231    mdutton@cardiosp.com   
Sponsors and Collaborators
QuesGen Systems Inc
Cardio Surgical Partners
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: QuesGen Systems Inc
ClinicalTrials.gov Identifier: NCT03604133    
Other Study ID Numbers: 2018-310 Cardiac Registry
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes