TYRX™ Pocket Health Study

Cardiac Disease Clinical Trial

Official title:

TYRX™ Pocket Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356546
• Other study ID #: MDT21029
• Status: Completed
• Start date: May 31, 2022
• Est. completion date: July 6, 2023

Study information

• Verified date: August 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.

Description:

The TYRX™ Pocket Health Study is a prospective, multi-center, single arm, post-market non-interventional study. This global study is planned to be conducted in geographies including, but not limited to, the United States (US), Canada, and Europe, at approximately 5 to 10 centers and will enroll up to 35 subjects with analyzable tissue samples. All enrolled subjects must have an existing CIED (implantable pulse generator (IPG), cardiac resynchronization therapy pacemaker (CRT-P), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)) that was implanted with the TYRX™ Absorbable Antibacterial Envelope and are returning for a clinically indicated CIED generator replacement without the planned addition of new or revision of existing leads.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Previously underwent a transvenous CIED implantation utilizing TYRX™ Absorbable Antibacterial Envelope and is returning for a CIED replacement procedure without planned addition of new or revision of existing leads at least 12 months from the prior CIED implant with use of TYRX™ Absorbable Antibacterial envelope (TYRX procedure of interest) a. Participants with history of one or two prior CIED implantation(s) at current implant site can be included, provided there was no invasive intervention to the pocket since the TYRX procedure of interest, defined by Exclusion Criteria #2

2. Age is = 18 years (or meets age requirements per local law) at time of enrollment

3. Procedure information from participant's TYRX procedure of interest can be obtained

1. Date of the TYRX procedure of interest

2. Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest

4. Provides signed and dated authorization and/or consent per institution and local requirements

5. Willing and able to comply with the protocol

Exclusion Criteria:

1. Active infection involving the CIED implant site (physical, clinical, or laboratory signs/symptoms consistent with an active infection at time of replacement procedure, including but not limited to pneumonia, urinary tract, cellulitis, endocarditis, or bacteremia)

2. Prior history of requiring invasive intervention to the pocket since the TYRX procedure of interest, including but not limited to lead revisions or CIED infection

3. Prior history of skin infection at CIED implant site since the TYRX procedure of interest

4. Returning for a CIED extraction, system upgrade, CIED replacement with planned lead addition and/or revision, planned lead revision, or pocket revision (e.g., pocket revision due to pain)

5. Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD)

6. Existing Ventricular Assist Device (VAD)

7. Currently receiving hemodialysis or peritoneal dialysis therapy

8. Current therapy with chronic oral immunosuppressive agents or = 20mg/day of Prednisone (or equivalent)

9. Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED)

10. Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence

11. Legally incompetent or otherwise vulnerable

12. Participation in another study that may potentially confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic

Related Conditions & MeSH terms

• Cardiac Disease
• Healing Surgical Wounds
• Heart Diseases
• Surgical Wound

Intervention

Other:
• Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection
Enrolled participants will have already received the TYRX™ Absorbable Antibacterial Envelope and will be clinically indicated to have a replacement with any market-released, commercially available (in the geographies they are used) CIED and lead(s) with or without the use TYRX™ Absorbable Antibacterial Envelope, as prescribed by and used on-label by their physician.

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Québec
Italy	Policlinico Sant Orsola - Malpighi	Bologna
United Kingdom	Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Tallahassee Research Institute	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphology of device capsule tissue	Measurement of capsule wall thickness (measured in millimeters, mm) in tissue sample	CIED Replacement Procedure
Primary	Histology of device capsule tissue	Histopathologic examination of tissue sample for extent of fibrosis, inflammation, vascularization, calcification, and adhesions, based on ordinal scoring scale	CIED Replacement Procedure