Clinical trial NCT04645173: Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation
Official title: A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent one or more prior CIED implantation procedure at the current implant site utilizing CanGaroo®, TYRX™, or no envelope and are returning for a CIED change-out or revision procedure.

Brief summary: The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.

Detailed description: This multi-center study will enroll up to approximately 100 participants who have undergone one or more implantations of a CIED with either CanGaroo®, TYRX™, or no envelope (up to approximately 30-35 participants per cohort) and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.

Once enrolled, each participant will have their medical history data collected (baseline demographics, medical history, prior CIED exchanges/revisions, and post implant clinical events). Prior to the scheduled change-out/revision procedure, there will be an assessment of the current healed implant site skin incision independently by both the participant and investigator using the Patient and Observer Scar Assessment Scale (POSAS), as well as photographs taken of the current skin scar.

During the change-out/revision procedure, additional investigator assessments will include photographic documentation of CIED implant pocket lining, classification of the extent of lead adhesions in the implant pocket, and biopsies of the anterior and posterior capsule walls for histologic analysis. Procedural details and any complications/AEs that occur during the change-out/revision procedure will also be captured.

Eligibility criteria: Inclusion Criteria:

1. Participants who previously underwent one or more prior CIED implantations utilizing a CanGaroo® envelope, TYRX™ envelope, or no envelope and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
2. The following possible scenarios would be eligible for enrollment:

   a. One prior CIED Implant: i. No envelope ii. CanGaroo® envelope iii. TYRX™ envelope b. Multiple prior CIED Implants (envelope type should remain the same for each participant throughout their implant history): i. No envelope → no envelope ii. No envelope → CanGaroo® envelope iii. No envelope → TYRX™ envelope iv. CanGaroo® envelope → CanGaroo® envelope v. TYRX™ envelope → TYRX™ envelope vi. No envelope → CanGaroo® envelope → CanGaroo® envelope vii. No envelope → no envelope → CanGaroo® envelope viii. No envelope → TYRX™ envelope → TYRX™ envelope ix. No envelope → no envelope → TYRX™ envelope
3. Participants aged 18 years or older at time of enrollment.
4. Participant is able and agrees to provide written informed consent and use of PHI.
5. Participants for whom prior CIED implant history information can be obtained.

Exclusion Criteria:

1. Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
2. Participants under the age of 18 at time of enrollment.
3. Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded:

   1. CanGaroo® envelope → TYRX™ envelope
   2. TYRX™ envelope → CanGaroo® envelope
   3. CanGaroo® envelope - no envelope
   4. TYRX™ envelope → no envelope
   5. No envelope → CanGaroo® envelope → no envelope
   6. No envelope → TYRX™ envelope → no envelope
   7. No envelope → CanGaroo® envelope → TYRX™ envelope
   8. No envelope → TYRX™ envelope → CanGaroo® envelope
   9. CanGaroo® envelope → no envelope → TYRX™ envelope
   10. TYRX™ envelope → no envelope → CanGaroo® envelope
   11. CanGaroo® envelope → TYRX™ envelope → no envelope
   12. TYRX™ envelope → CanGaroo® envelope → no envelope
   13. CanGaroo® envelope → CanGaroo® envelope → no envelope
   14. TYRX™ envelope → TYRX™ envelope → no envelope
4. Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.

Primary outcomes:
measure: Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall
timeFrame: Surgical Procedure Visit
Secondary outcomes:
measure: Documented CIED Complications
timeFrame: Pre-Surgery Visit
Other outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Pre-Surgery Visit
measure: CIED Scar Photographs
timeFrame: Pre-Surgery Visit
measure: CIED Implant Photographs
timeFrame: Surgical Procedure Visit
measure: Assessment of Lead Adhesions within the Implant Pocket
timeFrame: Surgical Procedure Visit
Locations:
city: Chandler
country: United States
facility: Valley Heart Rhythm Specialists
state: Arizona
city: Bay Pines
country: United States
facility: Bay Pines VA
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative / St. John's Hospital
state: Illinois
city: Louisville
country: United States
facility: U of L Health/Jewish Hospital
state: Kentucky
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Concord
country: United States
facility: Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University/Vidant Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
References: