Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Device: DragonFire Transcatheter Myocardial Radiofrequency Ablation System

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The treament of DragonFire Transcatheter myocardial ablation system; If drug therapy does not work or drug side effects are not tolerated, transaortic interventional surgery can be evaluated	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success	The device arrived at the intended treatment site for ablation, and was successfully withdrawn after ablation	Immediately after procedure
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
Incidence of device or device-related adverse events and device defects		12 months
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

Collaborators and Investigators

• Sponsor: Hangzhou Valgen Medtech Co., Ltd
• Investigators: Principal Investigator: Fang ZhenFei, Phd, The Second Xiangya Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): December 6, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: DragonFire-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No