Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507579
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Hydra Registry - Sheffield Experience
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation TAVI using the Hydra transcatheter aortic heart valve THV series in patients with severe aortic stenosis up to 1-year after the procedure This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views
The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram ECG monitoring using the novel Checkpoint Cardio System
The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram ECG monitoring using the novel Checkpoint Cardio System
Detailed Description:
This is a prospective observational single-center study The study center will be the Sheffield Teaching Hospitals NHS Foundation Trust Sheffield England The aim of this study is to collect clinical procedural and follow-up data in order to evaluate the efficacy and safety of the Hydra THV series Vascular Innovations Co Ltd Nonthaburi Thailand Additionally the study will conduct the remote ambulatory cardiac monitoring rACM using the Checkpoint Cardio System consisting of 72 hours of continuous electrocardiogram ECG monitoring will be evaluated post hospital discharge and coronary access will be evaluated immediately post-TAVI by attempting to selectively engage both the right and left coronary arteries through standardized angiographic views The operator will attempt to achieve commissural alignment for the Hydra THV series using the commissural alignment technique as specified in section 34 of this protocol contingent upon the patients condition during the procedure Following discharge clinical follow-ups are scheduled at 1-month 7 days and 1-year 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None