Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638268
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock - the TACTICS Study - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
TACTICS
Brief Summary:
The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation TAVI is superior to standard treatment stabilization in an intensive care unit and TAVI subsequently to treat cardiogenic shock in patients with critical severe aortic stenosis
The main questions it aims to answer are
Does acute TAVI increase survival compared with standard treatment
Participants will
Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission
Visit an outpatient clinic and be evaluated for quality of life and heart function
The main questions it aims to answer are
Does acute TAVI increase survival compared with standard treatment
Participants will
Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission
Visit an outpatient clinic and be evaluated for quality of life and heart function
Detailed Description:
Aortic stenosis AS is a condition where the hearts aortic valve narrows With an estimated prevalence of 12 in individuals aged 75 years and above it is the most common heart valve disease The progressive narrowing increases the afterload on the heart impairing its ability to maintain cardiac output The end-stage of critical AS is cardiogenic shock CS with an incidence of 35 to 12 Without treatment patients develop acute decompensation organ failure and ultimately die
Guidelines suggest balloon aortic valvuloplasty BAV hemodynamic optimization in the intensive care unit and surgical aortic valve replacement or transcatheter aortic valve implantation TAVI when the patient is stable Even with BAV the 30-day mortality is 33-47 and a 1-year mortality is 70 Further the BAV procedure is associated with only a minor and likely temporary reduction in afterload due to elastic valvular tissue Furthermore the BAV procedure has been abandoned as a routine intervention in these patients due to a series of patients having limited immediate clinical response a risk of deterioration and no impact on overall mortality risk Moreover most patients with critical AS in CS are not candidates for surgical aortic valve replacement because of increased peri-operative risk of morbidity and mortality
Despite the recommendation on TAVI under stable conditions an acute TAVI may be efficient in afterload reduction and more efficient than the limited and transient effects of BAV TAVI has become an attractive alternative to surgery and BAV because of the less invasive nature of this procedure yet permanent result compared with BAV It is already approved for the treatment of AS irrespective of CS status This raises the question
Should acute TAVI be the new preferred treatment strategy in AS patients in Cardiogenic shock
In this randomized controlled trial we will include patients with severe aortic stenosis and cardiogenic shock Patients will undergo either acute TAVI or standard treatment stabilization in a cardiac intensive care unit and subsequently TAVI in a 11 ratio Outcomes are evaluated 90 days after randomization and comprise days alive out of hospital mortality cardiac function renal function and quality of life
Guidelines suggest balloon aortic valvuloplasty BAV hemodynamic optimization in the intensive care unit and surgical aortic valve replacement or transcatheter aortic valve implantation TAVI when the patient is stable Even with BAV the 30-day mortality is 33-47 and a 1-year mortality is 70 Further the BAV procedure is associated with only a minor and likely temporary reduction in afterload due to elastic valvular tissue Furthermore the BAV procedure has been abandoned as a routine intervention in these patients due to a series of patients having limited immediate clinical response a risk of deterioration and no impact on overall mortality risk Moreover most patients with critical AS in CS are not candidates for surgical aortic valve replacement because of increased peri-operative risk of morbidity and mortality
Despite the recommendation on TAVI under stable conditions an acute TAVI may be efficient in afterload reduction and more efficient than the limited and transient effects of BAV TAVI has become an attractive alternative to surgery and BAV because of the less invasive nature of this procedure yet permanent result compared with BAV It is already approved for the treatment of AS irrespective of CS status This raises the question
Should acute TAVI be the new preferred treatment strategy in AS patients in Cardiogenic shock
In this randomized controlled trial we will include patients with severe aortic stenosis and cardiogenic shock Patients will undergo either acute TAVI or standard treatment stabilization in a cardiac intensive care unit and subsequently TAVI in a 11 ratio Outcomes are evaluated 90 days after randomization and comprise days alive out of hospital mortality cardiac function renal function and quality of life
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