Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557798
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
REVALVE
Brief Summary:
Transcatheter aortic valve implantation TAVI is a key-hole technique to replace an aortic heart valve that is narrowed andor leaking Although TAVI is a safe and effective treatment for a faulty aortic heart valve the new TAVI valve will not last forever Because it is a tissue valve made from the lining of a cow or pig heart the valve will fail after a period of time as the tissue degenerates
When the TAVI valve fails a viable treatment option is to perform a Redo TAVI procedure implanting a second TAVI valve inside the first failing valve
The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure The study will also obtain information about which factors predict those outcomes
The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI and instead are treated either by open-heart surgery and surgical aortic valve replacement or by medical therapy medication
The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients
When the TAVI valve fails a viable treatment option is to perform a Redo TAVI procedure implanting a second TAVI valve inside the first failing valve
The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure The study will also obtain information about which factors predict those outcomes
The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI and instead are treated either by open-heart surgery and surgical aortic valve replacement or by medical therapy medication
The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients
Detailed Description:
To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation TAVI for the treatment of Bioprosthetic Valve Failure BVF affecting Transcatheter Aortic Heart Valves THVs
To determine the factors which predict the acute and long-term outcomes of Redo TAVI
To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team
To determine the acute and long-term outcomes of surgical explantation and surgical aortic valve replacement SAVR for the treatment of BVF affecting THVs
To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy OMT - balloon aortic valvuloplasty BAV
To determine the factors which predict the acute and long-term outcomes of Redo TAVI
To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team
To determine the acute and long-term outcomes of surgical explantation and surgical aortic valve replacement SAVR for the treatment of BVF affecting THVs
To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy OMT - balloon aortic valvuloplasty BAV
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