Brachial Right Ventricle - Endomyocardial Biopsy

NCT05289180 | Completed

• 1 other identifier: 21-01132
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants undergoing Heart Catherization

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.

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

Participants undergoing Heart Catherization

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Right heart endomyocardial biopsy is classically approached via jugular or femoral access. Brachial access has not been widely studied and appears to be an efficient and safe method for performing endomyocardial biopsies. We hypothesize that transbrachial right endomyocardial biopsy is a safe, comfortable and equally effective procedure to endomyocardial biopsies via classical access methods. This single arm study will focus on brachial endomyocardial biopsy and will be compared with historical data.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tajinderpal Saraon

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: October 24, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Tajinderpal.Saraon@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)