Brachial Right Ventricle - Endomyocardial Biopsy

Heart Transplantation Clinical Trial

Official title:

A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289180
• Other study ID #: 21-01132
• Status: Completed
• Start date: October 24, 2022
• Est. completion date: December 8, 2023

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study that will recruit NYU Langone patients undergoing standard of care right ventricle endomyocardial biopsy. Patients who undergo planned RV-EMB via transbrachial access will be invited to take part in the study.

Description:

Data including severity of tricuspid regurgitation and tamponade from pre and post procedure bedside echocardiograms, total procedure duration, radiation exposure and fluoroscopy time, sedatives used (if any) and bleeding/hematoma formation (if any) will be collected. A post-procedural survey will be administered to patients by study staff to assess comfort level and anxiety during procedure. A post procedure phone call will take place 3-5 days after procedure to assess for bruising, swelling or bleeding at the site of Brachial RV-EMB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient is 18 to 90 years old
• Patient is undergoing standard of care right heart catheterization with endomyocardial biopsy
• Patient has right arm brachial access available
• Patient is willing and able to provide written informed consent.

Exclusion Criteria:

• Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
• Severe untreated tricuspid valve regurgitation
• Female patients who are pregnant

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Other:
• Questionnaires
A questionnaire will be administered post-procedure to assess for pain and anxiety. This questionnaire will be administered by study personnel delegated to administer questionnaires, namely the study coordinator or PI.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction in Right endomyocardial biopsy via brachial access	Assessed by patients self report of their experience when undergoing right endomyocardial biopsy via brachial access compared to transjugular and transfemoral right ventricle endomyocardial biopsy.	Day 1 to Day 540