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Construction of a Transinterval Biventricular Myocardial Biopsy Technique System Mediated by the L-S-M Method via the Venous System and Its Application in Precision Diagnosis and Treatment of Cardiovascular Diseases.

Construction of a Transinterval Biventricular Myocardial Biopsy Technique System Mediated by the L-S-M Method via the Venous System and Its Application in Precision Diagnosis and Treatment of Cardiovascular Diseases.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115854
Enrollment
Unknown
Registered
2025-12-31
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular heart disease

Interventions

L-S-M biopsy:Patients with various cardiovascular diseases who plan to undergo endomyocardial biopsy and receive L-S-M biventricular biopsy.
Non L-S-M biopsy:Various cardiovascular disease patients who plan to undergo endomyocardial biopsy and undergo traditional biopsy forceps endomyocardial biopsy.

Sponsors

Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. >= 18 years old. 2. Patients with cardiomyopathy or arrhythmia who require endomyocardial biopsy according to the 2023 ESC management guidelines and the 2025 Chinese comprehensive management guidelines for cardiomyopathy. 3. Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe coronary artery disease (with a clear history of recent severe coronary artery bypass surgery or percutaneous coronary intervention, and a clinical history of myocardial infarction within the past month). 2. Reject the endomyocardial biopsy technique. 3. Contraindications for endomyocardial biopsy, such as severe liver, lung, kidney dysfunction, bleeding disorders, severe thrombocytopenia, and those undergoing anticoagulant therapy. 4. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterate individuals, etc.

Design outcomes

Primary

MeasureTime frame
Feasibility of obtaining left and right myocardial biopsies, Surgical success rate, incidence of complications (pericardial tamponade, embolism, conduction block, etc.);

Secondary

MeasureTime frame
Additional assessment items for myocardial samples: 1. Outsourced multi-omics testing (1 time in total, approximately 10-50mg, for detecting proteins, metabolites, RNA, etc.). 2. Peripheral blood samples (1 time in total, approximately 2mL per time, for proteomics and metabolite detection).;Sample adequacy rate, tissue quality score, and accuracy of biopsy diagnosis.;

Countries

China

Contacts

Public ContactYe Yang

Run Run Shaw Hospital, Zhejiang University School of Medicine

yeyang1222@163.com+86 139 5810 3062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026