Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368037
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy
Sponsor:
Hangzhou Valgen Medtech Co Ltd
Organization:
Hangzhou Valgen Medtech Co Ltd
Study Overview
Official Title:
To Evaluate the Safety and Feasibility of the DragonFire Transcatheter Radiofrequency Myocardial Ablation System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None