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A Prospective, Multicenter, Single-Arm Objective Performance Criteria-Controlled Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Ablation System and Radiofrequency Ablation Electrode in the treatment of Hypertrophic Cardiomyopathy

A Prospective, Multicenter, Single-Arm Objective Performance Criteria-Controlled Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Ablation System and Radiofrequency Ablation Electrode in the Treatment of Hypertrophic Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039957
Enrollment
Unknown
Registered
2020-11-15
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Hypertrophic Cardiomyopathy

Interventions

experimental group:Radiofrequency Ablation System and Radiofrequency Ablation Electrode

Sponsors

The First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with hypertrophic cardiomyopathy (LVOT pressure gradient >= 50mmhg (at rest or after challenge)); 3. Patients with obvious clinical symptoms, such as fatigue, shortness of breath, exertional angina pectoris, syncope, etc., which seriously affect the quality of life, have poor effect of adequate drug treatment or can not tolerate the side effects of drugs; 4. Patients who can understand the purpose of the clinical trial voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with non obstructive hypertrophic cardiomyopathy; 2. Patients with history of ventricular septal circumcision or alcohol ablation; 3. Patients with active infection who need antibiotic treatment at the same time; 4. Patients with other heart diseases requiring surgical treatment; 5. Patients with heart failure (after intensive anti heart failure treatment, they still have symptoms of resting heart failure, left ventricular ejection fraction = 5000pg / ml); 6. Subjects with coronary ischemic events within 30 days; 7. Patients with significant coronary artery lesions requiring PCI revascularization therapy; 8. Patients with bleeding constitution and coagulation disorders, or contraindications of anticoagulation and antiplatelet therapy; 9. Patients with renal insufficiency (serum creatinine > 2.0mg/dl or 177 µ mol / L) or receiving dialysis treatment; 10. Pregnant and lactating women; 11. Patients with diseases that may cause difficulties in the evaluation of treatment (such as cancer, severe metabolic diseases, psychosis, etc.); 12. Patients with primary end-point events in recent 6 months (cardiac arrest, survival or appropriate discharge of implantable cardioverter defibrillator (ICD)) and secondary end-point events (meeting any of the following requirements: hospitalization for heart failure, thromboembolism, end-stage HCM); 13. Patients who are allergic to anesthetics and can not tolerate general anesthesia; 14. Patients with life expectancy less than 12 months; 15. Patients who participated in any drug and / or medical device clinical trials within one month before the trial; 16. The researchers judged that the patients' compliance was poor and they were unable to complete the study according to the requirements.

Design outcomes

Primary

MeasureTime frame
Echocardiography;Exercise Stress Echocardiography;Acoustic Contrast;CTA;MRI;24h Ambulatory Blood Pressure;24h Holter;Standard 12-Lead ECG;Myocardial Contrast Echocardiography;

Countries

China

Contacts

Public ContactLiwen Liu

The First Affiliated Hospital of Air Force Medical University

liuliwen@fmmu.edu.cn+86 29-84771671

Outcome results

None listed

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