Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343363
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-10-29
Brief Title:
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair an Assessment of Feasibility and Safety
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair an Assessment of Feasibility and Safety
Status:
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:
EARLY-Edge
Brief Summary:
Mitral regurgitation MR and tricuspid regurgitation TR are common causes of breathlessness fluid retention and other heart failure symptoms which lead to reduced quality of life and frequent hospitalisation These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities leaving them with few treatment alternatives
Transcatheter edge-to-edge repair TEER procedures have increasingly been used to improve the severity of both MR and TR offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay The standard of care in the UK and particularly in Oxford emphasises fewer investigations before the TEER procedure and shorter length of hospital stay
This prospective observational cohort study will examine the safety and feasibility of this practice
Transcatheter edge-to-edge repair TEER procedures have increasingly been used to improve the severity of both MR and TR offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay The standard of care in the UK and particularly in Oxford emphasises fewer investigations before the TEER procedure and shorter length of hospital stay
This prospective observational cohort study will examine the safety and feasibility of this practice
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?:
True
Is an FDA AA801 Violation?:
None