TYRX™ Pocket Health Study

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05356546
Study type	Observational
Source	Medtronic Cardiac Rhythm and Heart Failure
Contact
Status	Completed
Phase
Start date	May 31, 2022
Completion date	July 6, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05490303` - HeartGuide: Preliminary Study	N/A
Completed	`NCT05070819` - Atrial Natriuretic Peptide in Assessing Fluid Status	N/A
Not yet recruiting	`NCT04511403` - Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Completed	`NCT02697760` - The CZT Dynamic Myocardial Perfusion Imaging
Terminated	`NCT05157568` - Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation	N/A
Not yet recruiting	`NCT04160845` - Non-invasive Forehead Skin Temperature in Cardiac Surgery
Completed	`NCT04500912` - Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population	N/A
Not yet recruiting	`NCT06438159` - Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.	N/A
Recruiting	`NCT06154473` - Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
Not yet recruiting	`NCT05877755` - Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging	N/A
Completed	`NCT03394859` - Electronic Medical Records and Genomics (eMERGE) Phase III
Recruiting	`NCT05055830` - Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Recruiting	`NCT04374799` - Heparin vs Placebo for Cardiac Catheterization	Phase 3
Completed	`NCT03174106` - Longterm Follow-up of Cardiac Patients With an Smartphone-Application	N/A
Recruiting	`NCT05531253` - Respired Gases in Patients Post Cardiac Surgery
Recruiting	`NCT04609228` - Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
Recruiting	`NCT06149143` - Cardiac Performance System Data Collection Study - Minnesota
Recruiting	`NCT05725655` - Hot Water Immersion After Myocardial Infarction	N/A
Recruiting	`NCT06073509` - Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT