Clinical trial NCT04846127: CanGaroo® Registry Study
Official title: A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 500 participants who will either receive a CanGaroo envelope or no envelope during their de novo cardiac implantable electronic device implantation.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association between participant characteristics and outcomes
timeFrame: 3 months post-procedure
measure: Association between CanGaroo envelope use and CIED implant-related outcomes and events.
timeFrame: 3 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Daytona Beach
country: United States
facility: Daytona Heart Group
state: Florida
city: Delray Beach
country: United States
facility: The Arrhythmia Center of South Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists, PLLC
state: Florida
city: Gainesville
country: United States
facility: VA Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Cardiovascular Associates/Osceola Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: Advent Health
state: Florida
city: New Albany
country: United States
facility: Baptist Health Floyd
state: Indiana
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Brigham & Women's Hospital, Cardiovascular Division
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Wyoming
country: United States
facility: Metro Health/University of Michigan Health
state: Michigan
city: Raleigh
country: United States
facility: UNC Health/NC Heart & Vascular Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Mercy Health
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University Center for Health Sciences
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: The Woodlands
country: United States
facility: Heart Rhythm Associates
state: Texas
Study officials:
affiliation: Piedmont Heart Institute
name: Thomas F. Deering, MD
role: PRINCIPAL_INVESTIGATOR
References: