Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309524
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge DellInsufficienza Tricuspidale Severa
Status:
RECRUITING
Status Verified Date:
2024-03
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:
HERITAGE
Brief Summary:
In the recent years secondary tricuspid regurgitation STR has gained interest due to its high prevalence and impact on outcomes Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results Treatment options mimic surgical techniques such as leaflet approximation direct annuloplasty and heterotopic caval valve implantation as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation 5 Among leaflet approximation techniques the Tricuspid transcatheter edge-to-edge repair T-TEER using the TriClip Abbott Vascular Santa Clara CA USA or leaflet approximation with the PASCAL systems Edwards Lifesciences Irvine CA USA are approved in Europe for minimally invasive TV repairThe purposes of the present study are i to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR ii to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet iii to compare the accuracy of 3DE assessment of the right ventricle the right atrium and the tricuspid annulus with the same parameters obtained by CCT in the setting of T-TEER and iv to assess patients outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None