Status:
ACTIVE_NOT_RECRUITING
Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy
Lead Sponsor:
Hangzhou Valgen Medtech Co., Ltd
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this ...
Detailed Description
This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Obstructive hypertrophic cardiomyopathy, peak LVOT pressure difference ≥50mmHg at rest or after excitation;
- Obvious clinical symptoms, fatigue, shortness of breath, fatigue angina pectoris, syncope, etc., seriously affect the quality of life, and adequate drug treatment is not effective or can not tolerate drug side effects, after evaluation, transaortic interventional surgery can be performed;
Exclusion
- Women who are pregnant, breastfeeding, or planning to become pregnant;
- interventricular septum thickness ≥30mm;
- non-hypertrophic obstructive cardiomyopathy;
- Presence of cardiac neoplasms;
- A history of interventricular septal resection or alcohol ablation, or Liwen surgery;
- Combined with other heart diseases requiring surgical treatment;
- Heart failure (after intensive anti-heart failure treatment, there are still symptoms of resting heart failure, such as left ventricular ejection fraction \< 50%, N-terminal -B type natriuretic peptide precursor, NT-pro BNP≥5000pg/ml, pulmonary edema, pleura or pericardial effusion, etc.);
- Significant coronary lesions, or borderline lesions, requiring coronary revascularization due to mismatch between coronary perfusion and demand (QFR or FFR \< 0.8), or coronary ischemic events within 30 days;
- Bleeding diseases or clotting disorders; Or there is a contraindication of antithrombotic drug therapy;
- estimated Glomerular Filtration Rate (eGFR) \< 35ml/min;
- Life expectancy was less than 12 months, and the investigator judged that the patient had poor compliance and could not complete the study as required; Or other circumstances in which the investigator considers the subject unsuitable for the study;
- Subject is currently participating in an investigational drug or device study that has not completed its primary endpoint or that would clinically interfere with the endpoint of this study.
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06211595
Start Date
October 13 2022
End Date
November 30 2024
Last Update
January 18 2024
Active Locations (1)
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1
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China