Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

Official title:

To Evaluate the Safety and Feasibility of the DragonFire Transcatheter Radiofrequency Myocardial Ablation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06211595
• Other study ID #: DragonFire-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Hangzhou Valgen Medtech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 30, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Device:
• DragonFire Transcatheter Myocardial Radiofrequency Ablation System
The patients with hypertrophic obstructive cardiomyopathy were treated with a transcatheter myocardial radiofrequency ablation system and its guiding system under the guidance of echocardiography

Locations

Country	Name	City	State
China	The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Valgen Medtech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MAE	Major adverse Event (MAE) is defined as any instrument-related or surgery-related complication, including death, emergency surgery, severe pericardial tamponade requiring pericardiocentesis or surgery, bleeding, surgery-related stroke, pacemaker implantation, and mechanically assisted circulation	30 days
Secondary	Acute procedural success	The device arrived at the intended treatment site for ablation, and was successfully withdrawn after ablation	Immediately after procedure
Secondary	Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of =50% or left ventricular outflow tract pressure (LVOTG) < 30mmHg	Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of =50% or LVOTG< 30mmHg after the procedure	12 months
Secondary	Incidence of device or device-related adverse events and device defects		12 months
Secondary	Quality of life improvement	Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire,a scale of 0-100 with higher scores indicating better health	6 months, 12months