Evaluating the safety of endocardial myocardial biopsy procedures
Clinical Study of Endocardial Myocardial Biopsy
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05718128 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on myocardial biopsy, this specific approach focusing on safety and comprehensive diagnostic evaluation is relatively novel.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.