Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

NCT06211595 | Unknown

• 1 other identifier: DragonFire-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute procedural success

  Immediately after procedure

• Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of ≥50% or left ventricular outflow tract pressure (LVOTG) < 30mmHg

  12 months

• Incidence of device or device-related adverse events and device defects

  12 months

• Quality of life improvement

  6 months, 12months

Study Arms (1)

The treament of DragonFire Transcatheter myocardial ablation system

EXPERIMENTAL

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

Interventions

DragonFire Transcatheter Myocardial Radiofrequency Ablation System DEVICE

The patients with hypertrophic obstructive cardiomyopathy were treated with a transcatheter myocardial radiofrequency ablation system and its guiding system under the guidance of echocardiography

The treament of DragonFire Transcatheter myocardial ablation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Fang ZhenFei, Phd

  The Second Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: October 13, 2022
• Primary Completion: December 6, 2023
• Study Completion: November 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)