Evaluating the safety of endocardial myocardial biopsy procedures
Official title: Clinical Study of Endocardial Myocardial Biopsy
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT05718128 · Data updated 2026-11-12
This study is testing the safety of a heart tissue biopsy procedure for patients with heart issues like myocarditis and cardiomyopathies to see how well it works and what risks it might have.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | June 1, 2031 |
| Study ends | June 1, 2031 |
| Registry record updated | March 28, 2023 |
| Trial ID | NCT05718128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with myocarditis, cardiomyopathy, heart failure, or cardiac tumors of unknown origin who are undergoing an endocardial myocardial biopsy.
✕Probably not a fit
Patients who are unable to understand the informed consent process or unwilling to participate in follow-up assessments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study focuses on patients undergoing endocardial myocardial biopsy to assess the safety of the procedure and perform pathological examinations. It includes additional tests such as viral examinations and molecular biology assessments to confirm diagnoses related to myocarditis, cardiomyopathies, heart failure, and cardiac tumors. Patients will be monitored and followed up to gather comprehensive data on outcomes and safety.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cardiac conditions and improve diagnostic accuracy for patients with unclear heart issues.
How similar studies have gone: While there have been studies on myocardial biopsy, this specific approach focusing on safety and comprehensive diagnostic evaluation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the Second Affiliated Hospital of Zhejiang University School of Medicine; * Patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause; * Have the ability to understand the test, can cooperate with investigators. Exclusion Criteria: * Unable to understand or unwilling to fill in informed consent forms or follow visitors.
Where it's running
-
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: XiaoHong PAN
- Email: heartpanxh@163.com
- Phone: +8613857116993
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.