Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
NCT Number: NCT06472934
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Stenosis
Interventions: OTHER: Transcatheter aortic valve replacement in the absence of B-blocker treatment|OTHER: Transcatheter aortic valve replacement
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 498
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-05
Locations: University Hospital Basel, Basel, 4031, Switzerland|Inselspital, Bern University Hospital, Bern, 3010, Switzerland|Geneva University Hospitals, Geneva, 1205, Switzerland|University Hospital of Zürich, Zürich, 8091, Switzerland

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.

Primary Outcome Measures: All-cause mortality, To analyse the safety of B-blocker discontinuation, the all-cause mortality, as part of a composite endpoint, is assessed within 30 days after transcatheter aortic valve replacement (TAVR)., At 30 days|Re-hospitalization due to heart failure, To analyse the safety of B-blocker discontinuation, the incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days after TAVR.

Re-hospitalization due to heart failure is defined as an admission occurring after the index hospitalization or study enrollment, where new or worsening heart failure is the primary reason for a hospital stay exceeding 24 hours. This determination is based on symptoms and signs of heart failure, confirmed by diagnostic tests, and requires treatment with intravenous or mechanical heart failure therapies. This includes both primary (cardiac-related) and secondary (non-cardiac-related) causes., At 30 days|Stroke Rate, To analyse the safety of B-blocker discontinuation, the incidence of stroke, as part of a composite endpoint, is assessed within 30 days after TAVR., At 30 days|Severe arrhythmia requiring treatment, To analyse the safety of B-blocker discontinuation, the incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days after TAVR.

Severe arrhythmia requiring treatment are e.g. new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new atrioventricular block (AB, first-, second- or third-degree), new left bundle branch block, new right bundle branch block, new severe bradycardia or tachycardia (\<40bpm or \>120bpm)., At 30 days
Secondary Outcome Measures: Permanent pacemaker implantation Rate, To analyse the efficacy of B-blocker discontinuation, the incidence of permanent pacemaker implantation is assessed within 30 days and 1 year after TAVR., At 30 days and 1 year|Stroke Rate, The incidence of stroke is assessed within 30 days and 1 year after TAVR., At 30 days and 1 year|All-cause mortality, The all-cause mortality is assessed within 30 days and 1 year after TAVR., At 30 days and 1 year|Cardiovascular mortality, The cardiovascular mortality is assessed within 30 days and 1 year after TAVR. It is defined as either:

* Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis),or other clear cardiovascular cause
* Intraprocedural death
* Sudden death
* Death of unknown cause, At 30 days and 1 year|Re-hospitalization due to heart failure, The incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days and 1 year after TAVR.

Re-hospitalization due to heart failure is defined as an admission occurring after the index hospitalization or study enrollment, where new or worsening heart failure is the primary reason for a hospital stay exceeding 24 hours. This determination is based on symptoms and signs of heart failure, confirmed by diagnostic tests, and requires treatment with intravenous or mechanical heart failure therapies. This includes both primary (cardiac-related) and secondary (non-cardiac-related) causes., At 30 days and 1 year|Severe arrhythmia requiring treatment, The incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days and 1 year after TAVR.

Severe arrhythmia requiring treatment are e.g. new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new atrioventricular block (AB, first-, second- or third-degree), new left bundle branch block, new right bundle branch block, new severe bradycardia or tachycardia (\<40bpm or \>120bpm)., At 30 days and 1 year
Other Outcome Measures: Health economic assessment, An assessment of the impact on health economic is performed, which includes information regarding the length of intensive care unit stay, length of hospital stay, rate of pacemaker implantation, and results of the Kansas City Cardiomyopathy quality of life Questionnaire (KCCQ-12) which ranges from 0 to 100 with higher scores indicating better health status and quality of life, while lower scores suggest more severe symptoms and poorer quality of life., At 30 days and 1 year