Heart TransplantationNCT05289180
Brachial Right Ventricle - Endomyocardial Biopsy
An observational study of Heart Transplantation, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Questionnaires
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 8 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
- Severe untreated tricuspid valve regurgitation
- Female patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy
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.
Read the 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.
- Conditions
- Heart Transplantation
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 540
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start24 Oct 2022
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tajinderpal Saraon, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289180
- Sponsor's protocol ID
- 21-01132
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy
- ClinicalTrials.gov ID
- NCT05289180
- Acronym / sponsor ID
- 21-01132
- Conditions
- Heart Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing Heart Catherization | – | Other: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
- Severe untreated tricuspid valve regurgitation
- Female patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesA 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. | Other | Participants undergoing Heart Catherization |
Primary outcome
Patient Satisfaction in Right endomyocardial biopsy via brachial access
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Yes. De-identified participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tajinderpal Saraon principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction in Right endomyocardial biopsy via brachial access (time frame: Day 1 to Day 540). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.