Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890821
Status:
RECRUITING
Last Update Posted:
2021-11-30
First Post:
2021-05-07
Brief Title:
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
Sponsor:
Cardiac Implants LLC
Organization:
Cardiac Implants LLC
Study Overview
Official Title:
Early Feasibility Study EFS of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation
Status:
RECRUITING
Status Verified Date:
2021-11
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:
An early feasibility study to evaluate the safety and performance of 1 the transcatheter delivery and implantation of the Cardiac Implants CI annuloplasty ring and 2 the adjustment of the ring approximately 90 days following implantation in patients suffering from moderate functional tricuspid regurgitation FTR
Detailed Description:
An early feasibility multi-center prospective single-arm non-randomized study to assess the safety and performance of the CI Percutaneous Ring Annuloplasty System in patients suffering from moderate functional tricuspid regurgitation FTR Additional outcomes include short and long-term changes in echocardiographic functional and quality of life parameters post-adjustment
The CI Ring Annuloplasty System is a percutaneous transcatheter repair device delivered by right heart catheterization through the right internal jugular vein The System is designed to perform annuloplasty using a Ring Delivery System RDS to place a complete flexible ring over the tricuspid annulus on the atrial side of the valve Fluoroscopy and transesophageal echocardiography are used to guide and monitor the ring placement procedure
After implantation the ring becomes embedded within the fibrous tissue of the tricuspid annulus Approximately 3 months following implantation the ring is manually adjusted under echocardiographic and fluoroscopic imaging using an Adjustment Tool AT until desired reduction of the tricuspid annulus dimension is achieved Following adjustment the AT releases a fastener securing the ring once optimal annular reduction is achieved
The CI Ring Annuloplasty System is a percutaneous transcatheter repair device delivered by right heart catheterization through the right internal jugular vein The System is designed to perform annuloplasty using a Ring Delivery System RDS to place a complete flexible ring over the tricuspid annulus on the atrial side of the valve Fluoroscopy and transesophageal echocardiography are used to guide and monitor the ring placement procedure
After implantation the ring becomes embedded within the fibrous tissue of the tricuspid annulus Approximately 3 months following implantation the ring is manually adjusted under echocardiographic and fluoroscopic imaging using an Adjustment Tool AT until desired reduction of the tricuspid annulus dimension is achieved Following adjustment the AT releases a fastener securing the ring once optimal annular reduction is achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None