Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06136182

Enrollment

489

Registered

2023-11-18

Start date

2023-05-12

Completion date

2026-04-08

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Outcome of Pericardial Closure Using Gentrix

Brief summary

A descriptive comparative project will be conducted to determine if there is a difference in outcomes for adult patients requiring pericardial reconstruction using CorMatrix compared to Gentrix

Detailed description

A descriptive, comparative project will be conducted utilizing a retrospective chart review on patients at Methodist Mansfield Medical Center(MMMC) undergoing cardiac surgery requiring pericardial repair between the dates of January 1, 2017 through December 31, 2022. The project will compare outcomes of a pre- and post-intervention following use of Gentrix ECM and the CorMatrix Extracellular Matrix(ECM) pericardial patch using information gathered from the patient's electronic health record (EHR). The main outcome measures of post-operative Length of Stay(LOS), all-cause unplanned readmission within 30 days, and significant pleural effusion requiring thoracentesis within 30-days and 60 days as well as long-term (12 months) patient outcomes.

Interventions

PROCEDUREPericardial Closure Using Gentrix Following Cardiac Surgery

To determine feasibility and effectiveness of Gentrix for cardiac use, and if this product is patient population specific.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction. CABG or valve repair/replacement surgery must have been either elective or urgent status

Exclusion criteria

-CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy

Design outcomes

Primary

Measure	Time frame	Description
Post-operative hospital LOS	30 days	30-day all-cause unplanned readmissions after discharge * Significant pleural effusion requiring thoracentesis within 30 days of surgery * Significant pleural effusion requiring thoracentesis within 60 days of surgery

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDarien Bradford, MD

Methodist Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026