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NCT04846127 Clinical Trial

CanGaroo® Registry Study

Arrhythmias, Cardiac Clinical Trial

Official title:
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04846127
Other study ID # CPR-2218
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date June 30, 2027

Study information
Verified date July 2023
Source Aziyo Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation

Description:

This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope. Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses. The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF. Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date June 30, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants for whom this is their first CIED implantation at a particular anatomical site. Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site. 2. Participants aged 18 years or older at time of enrollment. 3. Participant is able and agrees to provide written informed consent and use of PHI. Exclusion Criteria: 1. Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site. 2. Participants under the age of 18 at time of enrollment.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CanGaroo Envelope
Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.

Locations
Country Name City State
United States Eastern Maine Medical Center Bangor Maine
United States Brigham & Women's Hospital, Cardiovascular Division Boston Massachusetts
United States Daytona Heart Group Daytona Beach Florida
United States The Arrhythmia Center of South Florida Delray Beach Florida
United States Florida Heart Rhythm Specialists, PLLC Fort Lauderdale Florida
United States VA Medical Center Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States Houston Methodist Houston Texas
United States Cardiovascular Associates/Osceola Regional Medical Center Kissimmee Florida
United States Carolina Heart Specialists Lancaster South Carolina
United States Sparrow Clinical Research Institute Lansing Michigan
United States St. Joseph Hospital Lexington Kentucky
United States Arkansas Heart Hospital Little Rock Arkansas
United States Baptist Health Floyd New Albany Indiana
United States University of Pennsylvania Hospital Philadelphia Pennsylvania
United States UNC Health/NC Heart & Vascular Research Raleigh North Carolina
United States Ascension Providence Hospital Southfield Michigan
United States Advent Health Tampa Florida
United States Heart Rhythm Associates The Woodlands Texas
United States Mercy Health Toledo Ohio
United States Oklahoma State University Center for Health Sciences Tulsa Oklahoma
United States New Hanover Regional Medical Center Wilmington North Carolina
United States Metro Health/University of Michigan Health Wyoming Michigan

Sponsors (1)
Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association between participant characteristics and outcomes Cohort comparison of clinically significant factors such as physical and demographic characteristics, medical history risk factors related to post-procedure events, and associations with outcomes and events. 3 months post-procedure
Primary Association between CanGaroo envelope use and CIED implant-related outcomes and events. Cohort comparison of clinically significant events such as infection, wound healing issues, CIED migration, CIED erosion, or a revision/reoperation procedure. 3 months post-procedure
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