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Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

NCT06368037 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-16

No results posted yet for this study

Summary

This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yaling Han, Phd · Northern Theater Command General Hospital of the Chinese People's Liberation Army

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368037 on ClinicalTrials.gov