Clinical trial NCT06211595: Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy
Official title: To Evaluate the Safety and Feasibility of the DragonFire Transcatheter Radiofrequency Myocardial Ablation System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Hangzhou Valgen Medtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 study were treated. After signing an informed consent form, subjects are enrolled and treated with the DragonFire Transcatheter Myocardial Ablation System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, and 12 months after the procedure.

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 study were treated. After signing an informed consent form, subjects are enrolled and treated with the DragonFire Transcatheter Myocardial Ablation System. The primary efficacy endpoint was the rate of major adverse events 30 days after surgery. The safety endpoints were the rate of immediate postoperative success and postoperative device success All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, and 12 months after the procedure.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Obstructive hypertrophic cardiomyopathy, peak LVOT pressure difference ≥50mmHg at rest or after excitation;
3. 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 Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant;
2. interventricular septum thickness ≥30mm;
3. non-hypertrophic obstructive cardiomyopathy;
4. Presence of cardiac neoplasms;
5. A history of interventricular septal resection or alcohol ablation, or Liwen surgery;
6. Combined with other heart diseases requiring surgical treatment;
7. 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.);
8. 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;
9. Bleeding diseases or clotting disorders; Or there is a contraindication of antithrombotic drug therapy;
10. estimated Glomerular Filtration Rate (eGFR) \< 35ml/min;
11. 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;
12. 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.

Primary outcomes:
measure: Incidence of MAE
timeFrame: 30 days
Secondary outcomes:
measure: Acute procedural success
timeFrame: Immediately after procedure
measure: Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of ≥50% or left ventricular outflow tract pressure (LVOTG) < 30mmHg
timeFrame: 12 months
measure: Incidence of device or device-related adverse events and device defects
timeFrame: 12 months
measure: Quality of life improvement
timeFrame: 6 months, 12months
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: The Second Xiangya Hospital, Central South University
name: Fang ZhenFei, Phd
role: PRINCIPAL_INVESTIGATOR
References: