Brachial Right Ventricle - Endomyocardial Biopsy

NYU Langone Health

Status: Completed

Conditions: Heart Transplantation

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05289180

21-01132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

97 participants in 1 patient group

Participants undergoing Heart Catherization

Description:

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.

Treatment:

Other: Questionnaires