Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a multi-centric open-label randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement
Detailed Description:
Aortic stenosis AS is a common heart valve problem in older adults affecting about 5 of people over 65 It leads to symptoms like fainting chest pain difficulty breathing and heart failure which can increase the risk of serious health issues and death
Transcatheter Aortic Valve Replacement TAVR is a well-established treatment for severe AS especially for patients who are at high risk for traditional open-heart surgery TAVR is becoming more common and is now being used in younger and lower-risk patients due to its favorable outcomes
Many people with severe AS also have other heart conditions and beta-blockers B-blockers are commonly used to manage these issues B-blockers help treat heart failure irregular heartbeats high blood pressure and coronary artery disease About 34 to 51 of AS patients use B-blockers but these medications can also cause side effects like slow heart rate and low blood pressure
The need for a permanent pacemaker is the most common complication after TAVR occuring in 9 to 26 of patients This is because TAVR can affect the hearts electrical system B-blockers might increase the risk of needing a pacemaker because they can further slow down the hearts electrical signals
To reduce this risk doctors sometimes stop B-blockers around the time of TAVR However this practice lacks support from clinical trials or guidelines and stopping B-blockers can increase the risk of fast heartbeats and chest pain
This aim of the clinical trial is to study the impact of B-blocker administration among patients undergoing TAVR The trial will assess the safety of B-blocker discontinuation primary endpoint and by determining the incidence of permanent pacemaker implantation after TAVR secondary endpoint
The results of the trial will provide important insights into the optimal management of B-blockers in patients undergoing TAVR potentially improving patient outcomes and guiding clinical practice
Transcatheter Aortic Valve Replacement TAVR is a well-established treatment for severe AS especially for patients who are at high risk for traditional open-heart surgery TAVR is becoming more common and is now being used in younger and lower-risk patients due to its favorable outcomes
Many people with severe AS also have other heart conditions and beta-blockers B-blockers are commonly used to manage these issues B-blockers help treat heart failure irregular heartbeats high blood pressure and coronary artery disease About 34 to 51 of AS patients use B-blockers but these medications can also cause side effects like slow heart rate and low blood pressure
The need for a permanent pacemaker is the most common complication after TAVR occuring in 9 to 26 of patients This is because TAVR can affect the hearts electrical system B-blockers might increase the risk of needing a pacemaker because they can further slow down the hearts electrical signals
To reduce this risk doctors sometimes stop B-blockers around the time of TAVR However this practice lacks support from clinical trials or guidelines and stopping B-blockers can increase the risk of fast heartbeats and chest pain
This aim of the clinical trial is to study the impact of B-blocker administration among patients undergoing TAVR The trial will assess the safety of B-blocker discontinuation primary endpoint and by determining the incidence of permanent pacemaker implantation after TAVR secondary endpoint
The results of the trial will provide important insights into the optimal management of B-blockers in patients undergoing TAVR potentially improving patient outcomes and guiding clinical practice
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?:
None
Is an FDA AA801 Violation?:
None