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Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

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

NCT06211595•Hangzhou Valgen Medtech Co., Ltd

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

Locations (1)

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Key Dates

Start Date

October 13, 2022

Primary Completion Date

December 6, 2023

Completion Date

November 30, 2024

Last Updated

January 18, 2024

Enrollment

ACTUAL participants

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

DragonFire Transcatheter Myocardial Radiofrequency Ablation System

DEVICE

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

NCT07021976

Obstructive Hypertrophic Cardiomyopathy

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RECRUITING

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

NCT06023186

Obstructive Hypertrophic Cardiomyopathy

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NOT_YET_RECRUITINGNA

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

Inclusion Criteria

Exclusion Criteria

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy

A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM

Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy