Study on Safety and Diagnosis Using Endocardial Myocardial Biopsy for Heart Conditions in Adults 18 to 80 Years Old

What this Trial Is About

Researchers are evaluating the safety of endocardial myocardial biopsy in patients with heart conditions such as myocarditis, cardiomyopathy, heart failure, and cardiac tumors of unknown cause. This clinical study aims to observe the operations safety and perform pathological examinations, including special tests like viral examination, mass spectrometry, and molecular biology, to confirm diagnoses. The study is led by the Second Affiliated Hospital, School of Medicine, Zhejiang University and is a phase 4 interventional trial. The study involves patients undergoing the endocardial myocardial biopsy procedure, which is being assessed for safety and diagnostic value. If necessary, additional specialized tests are performed on biopsy samples to better understand the underlying cardiac condition. Participants are those who receive this biopsy procedure at the hospital and meet the studys eligibility criteria. During the study, researchers will follow participants over time to monitor safety and outcomes, including the incidence of major adverse cardiovascular events MACE-4 over a 10-year period. Participants will be observed and assessed through pathological examinations and follow-up visits. The study began in June 2021 and is planned to continue until June 2031, providing long-term safety data.

Clinical Study of Endocardial Myocardial Biopsy