Brachial Right Ventricle - Endomyocardial Biopsy

Completed

• Conditions: Heart Transplantation
• Interventions: Other: Questionnaires

• Registration Number: NCT05289180
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-21
• Study Start: 2022-10-24
• Primary Completion: 2023-12-08
• Study Completion: 2023-12-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants undergoing Heart Catherization	Questionnaires	Participants undergoing Heart Catherization and will complete a research survey focusing on the comfort and anxiety during procedure. Participants will be followed for 18 months after enrollment. For each clinically indicated Brachial RV-EMB Biopsy during the 18-month follow up period, data from biopsy and pre and post-procedure echocardiograms will be reviewed and recorded for research purposes. A post-procedure questionnaire and post-discharge phone call will also take place after each procedure.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction in Right endomyocardial biopsy via brachial access	Day 1 to Day 540	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States