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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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 Second Xiangya Hospital, Central South University
Changsha, Hunan, China
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
Time frame: 30 days
Acute procedural success
The device arrived at the intended treatment site for ablation, and was successfully withdrawn after ablation
Time frame: 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
Time frame: 12 months
Incidence of device or device-related adverse events and device defects
Time frame: 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
Time frame: 6 months, 12months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.