NCT06136182

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

July 6, 2023

Last Update Submit

April 27, 2026

Conditions

Clinical Outcome of Pericardial Closure Using Gentrix

Outcome Measures

Primary Outcomes (1)

  • Post-operative hospital LOS

    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

    30 days

Interventions

Pericardial Closure Using Gentrix Following Cardiac SurgeryPROCEDURE

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Must have undergone a CABG or valve repair/replacement surgery requiring pericardial reconstruction. * CABG or valve repair/replacement surgery must have been either elective or urgent status

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (3)

  • Bachar, B and Manna, B. (2022, August 8). Coronary Artery Bypass Graft. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK507836/

    BACKGROUND

  • Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.

    PMID: 30876459BACKGROUND

  • Valve repair or replacement (2022). In The Texas Heart Institute. https://www.texasheart.org/heart-health/heart-information-center/topics/valve-repair-or-replacement/

    BACKGROUND

Study Officials

  • Darien Bradford, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

November 18, 2023

Study Start

May 12, 2023

Primary Completion

April 8, 2026

Study Completion

April 8, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data Might be available by 2024 for up to 4 years
Access Criteria
All study-related documents will be retained by the clinical research institute (CRI) until at least three years after study completion or according to local laws, whichever is longer

Locations

US(2)