Obstructive Hypertrophic Cardiomyopathy
Conditions
Sponsors
Beijing Anzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =15 mm. 3. Resting or Valsalva-provoked left ventricular outflow tract peak gradient >=50 mm Hg. 4. Presented with drug-refractory symptoms or intolerant of pharmaceutical therapies. 5. Heart function >= New York Heart Association (NYHA) class III or NYHA class II with the following conditions: age = 100 mmHg; or experiencing mitral regurgitation >=3+ caused by systolic anterior motion (SAM) of the mitral valve during a resting state. 6. Informed of the nature of the clinical trial, consented to participate in all of the activities, and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presented with concomitant diseases, such as native valvular disease, coronary artery disease or myocardial bridge, which needed open-heart surgery. 2. Left ventricle ejection fraction of <40%. 3. Estimated life expectancy < 1 year due to non-cardiac comorbidities. 4. Pregnant or planning pregnancy within 12 months after surgery. 5. Recent (within 3 months) stroke. 6. Recent (within 3 months) gastrointestinal bleeding. 7. Need for emergency surgery. 8. Renal insufficiency (serum creatinine Cr exceeding 1.5 times the upper limit of normal) and/or end stage renal disease requiring dialysis. 9. Hepatic insufficiency: ALT or AST exceeding 2.5 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal. 10. Coagulation disorders: any of the following indicators—APTT, PT, TT, or INR—exceeding 10% of the normal reference range. 11. Hemoglobin levels < 80 g/L, platelet levels < 100 × 10^9/L, or serum albumin < 30 g/L; 12. History of chronic obstructive pulmonary disease (COPD) with severe obstructive ventilatory impairment. 13. History of prior organ transplantation. 14. Complete right bundle branch block. 15. Patients who are unable to cooperate with screening examinations due to specific reasons, such as inability to complete cardiac MRI due to atrial fibrillation or inability to perform Valsalva maneuver; 16. Patients diagnosed with malignant tumors. 17. Known to be allergic to heparin, contrast agents, or protamine. 18. Participating in clinical trials of other drugs or medical devices without achieving the primary endpoint or completing the primary endpoint observation for less than three months. 19. History of drug use and/or mental disorders. 20. According to the researchers' assessment, the subjects are deemed unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative device success rate;Technical success rate;Resting left ventricular outflow tract peak gradient;Provoked left ventricular outflow tract peak gradient;Grade of mitral regurgitation;Systolic anterior motion;Left ventricular outflow tract diameter;End-diastolic thickness of the 5 segments of the interventricular septum;Postoperative left ventricular myocardial mass and mass index;Left ventricular end-diastolic volume;N-terminal pro-B-type natriuretic peptide or Brain Natriuretic Peptide;cTnI/hs-cTnI/cTnT;Mitral valve replacement;Permanent pacemaker implantation;Surgical duration from skin incision to skin closure;Total volume of stored red blood cell transfusions during hospitalization (excluding autologous blood transfusions);Duration of tracheal intubation postoperatively;Duration of ICU stay postoperatively;Length of hospital stay postoperatively;New-onset atrial fibrillation postoperatively;Postoperative visual analog scale (VAS) pain score;Heart function of New York Heart Association Function;The distance of 6-minute walking test;Kansas City Cardiomyopathy Questionnaire score; | — |
Countries
China
Contacts
Public ContactYongqiang Lai
Beijing Anzhen Hospital
Outcome results
None listed