A Phase 4 interventional study of Beta blocker in Aortic Valve Stenosis, sponsored by National and Kapodistrian University of Athens. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by National and Kapodistrian University of Athens · Phase 4, Interventional, and Treatment
The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, non-inferiority trial designed to evaluate the safety of continuing versus temporarily interrupting chronic beta-blocker therapy in patients undergoing transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis.
A total of 348 patients receiving chronic oral beta-blocker therapy will be randomized in a 1:1 ratio to either continuation of their prescribed beta-blocker from at least 72 hours before TAVI through 7 days after the procedure or temporary interruption of beta-blocker therapy during the same period. Treatment modifications will be permitted when clinically indicated.
The primary objective is to determine whether beta-blocker continuation is non-inferior to interruption regarding the incidence of new permanent pacemaker implantation within 7 days after TAVI, using an absolute non-inferiority margin of 6.5 percentage points.
Secondary outcomes include atrioventricular conduction disturbances, atrial and ventricular arrhythmias, hemodynamic deterioration, subsequent permanent pacemaker implantation, and all-cause and cardiovascular mortality. Clinical follow-up will be performed at discharge, 7 days, 30 days, and 12 months after TAVI.
The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, controlled non-inferiority trial designed to investigate the impact of periprocedural beta-blocker continuation versus temporary interruption on conduction disturbances and clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI).
**Background and Rationale**
New-onset conduction disturbances and the subsequent need for permanent pacemaker implantation remain important complications following TAVI. Beta-blockers are frequently prescribed in this population for various cardiovascular indications, including heart failure, atrial fibrillation, coronary artery disease, and ventricular arrhythmias. However, the optimal management of chronic beta-blocker therapy during the periprocedural period remains uncertain.
Continuation of beta-blocker therapy may theoretically exacerbate bradycardia and atrioventricular conduction disturbances, potentially increasing the need for permanent pacemaker implantation. Conversely, abrupt discontinuation may lead to sympathetic rebound, tachyarrhythmias, myocardial ischemia, and hemodynamic instability. Available observational studies have reported conflicting findings, and randomized evidence directly comparing these strategies is lacking.
The BETA-TAVI trial aims to address this evidence gap by evaluating whether continuation of chronic beta-blocker therapy is non-inferior to temporary interruption regarding the incidence of new permanent pacemaker implantation within 7 days following TAVI.
**Study Design and Population**
The study will enroll 348 adult patients (174 per treatment group) with severe symptomatic aortic stenosis who are scheduled to undergo TAVI and are receiving chronic oral beta-blocker therapy for an established clinical indication.
Eligible participants must be considered suitable for TAVI following multidisciplinary Heart Team assessment and provide written informed consent. Key exclusion criteria include pre-existing permanent pacemakers or other implantable cardiac rhythm devices, advanced atrioventricular block, resting heart rate below 50 beats/min, and clinical conditions requiring mandatory continuation or discontinuation of beta-blocker therapy.
Participants will be randomized in a 1:1 ratio using a centralized allocation procedure to one of two treatment strategies:
All TAVI procedures and subsequent clinical management will follow contemporary guideline-based practice and local institutional standards. The choice of transcatheter heart valve, procedural technique, and postprocedural rhythm monitoring will remain at the discretion of the treating Heart Team. Decisions regarding permanent pacemaker implantation will be made according to established clinical indications, independently of treatment allocation.
**Study Objectives and Outcomes**
The primary objective is to determine whether continuation of chronic beta-blocker therapy is non-inferior to temporary interruption with respect to the incidence of new permanent pacemaker implantation within 7 days (168 hours) following TAVI.
The primary endpoint is the occurrence of new permanent pacemaker implantation from the start of the TAVI procedure through 7 days after intervention.
Secondary endpoints include:
Exploratory outcomes include temporary pacing duration, time to permanent pacemaker implantation, hospital length of stay, changes in electrocardiographic conduction parameters, and heart failure hospitalization.
Clinical and electrocardiographic assessments will be performed at baseline, during hospitalization, at discharge, and at 7 days, 30 days, and 12 months following TAVI. The primary endpoint and other prespecified clinical events will undergo blinded adjudication whenever feasible.
**Statistical Considerations**
The study is designed to test non-inferiority using an absolute risk-difference margin of 6.5 percentage points for the 7-day permanent pacemaker implantation rate, comparing beta-blocker continuation with interruption.
The planned sample size of 348 participants provides approximately 80% statistical power at a one-sided significance level of 0.025, based on anticipated event rates of 7.2% and 9.5% in the continuation and interruption groups, respectively, while allowing for limited non-evaluability.
The primary analysis will compare the absolute difference in event rates between treatment groups using a Miettinen-Nurminen score-based 95% confidence interval. Non-inferiority will be established if the upper confidence limit is below the prespecified margin of 6.5 percentage points in both the modified intention-to-treat and per-protocol populations.
Prespecified secondary, sensitivity, and subgroup analyses will further evaluate the consistency of treatment effects across clinically relevant patient and procedural characteristics.
**Clinical Significance**
The BETA-TAVI trial is intended to provide randomized evidence regarding the optimal periprocedural management of chronic beta-blocker therapy in patients undergoing TAVI. By assessing the balance between conduction-related complications and potential arrhythmic or hemodynamic consequences of beta-blocker interruption, the findings may inform clinical practice and contribute to the development of standardized medication-management strategies in this population.
1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
This study's planned enrollment of 348 is above the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →National and Kapodistrian University of Athens is the lead sponsor of 172 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population
Eligibility Adults scheduled to undergo TAVI for severe symptomatic aortic stenosis are eligible when they are receiving chronic oral beta-blocker therapy and satisfy all inclusion criteria without meeting any exclusion criterion.
Inclusion criteria Age 18 years or older. Severe symptomatic aortic stenosis, defined by one or more of the following: mean transvalvular gradient >=40 mmHg, peak aortic-jet velocity >=4.0 m/s, aortic-valve area \<=1.0 cm2, or indexed aorticvalve area \<=0.6 cm2/m2. Clinical and anatomical suitability for TAVI confirmed by the local multidisciplinary Heart Team.
Current oral beta-blocker treatment for a recognized clinical indication. Ability and willingness to comply with the assigned treatment strategy and follow-up schedule.
Written informed consent before any trial-specific procedure.
Exclusion criteria Existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Second-degree Mobitz II, advanced second-degree or third-degree atrioventricular block at screening, unless a permanent device is already clinically indicated independently of the trial.
Resting heart rate below 50 beats/min at the screening or baseline electrocardiogram.
A clinical condition requiring mandatory beta-blocker continuation or mandatory withdrawal such that randomization would be unsafe or inappropriate. Active infection, including active infective endocarditis. Left-atrial or left-ventricular thrombus on imaging. Contraindication to the antithrombotic regimen required for TAVI. Known hypersensitivity to required procedural drugs, contrast media or device components that cannot be adequately managed. Estimated life expectancy below 12 months because of non-cardiac disease. Pregnancy or potential for pregnancy without reliable contraception. Comorbidity or social circumstance expected to prevent reliable assessment of the 7-day primary endpoint or scheduled follow-up. Participation in another interventional study that is considered likely to interfere with the assigned treatment or endpoint assessment.
Patients assigned in the beta-blockers continuation arm will be receiving per os beta blocker medication for at least 72 hours before TAVI without interruption after it.
Drug: Beta blocker
Patients assigned to interrupt the beta-blockers treatment will abstain from beta blockers for at least 7 days after TAVI.
Drug: Beta blocker
Investigation on beta-blockers in TAVI and brief post-TAVI period.
Permanent pacemaker implantation
Permanent pacemaker implantation
Time frame: 7 days
All-cause mortality
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Cardiovascular mortality
Time frame: 12 months
Hemodynamic deterioration
Shock or circulatory instability requiring intravenous vasopressor or inotropic therapy, or mechanical circulatory support.
Time frame: 12 months
Atrial fibrillation or flutter
New documented atrial fibrillation/flutter in a participant without that rhythm at baseline; recurrent clinically documented episodes will also be reported separately.
Time frame: 12 months
Sustained ventricular arrhythmia
Sustained ventricular tachycardia or ventricular fibrillation requiring intervention or lasting at least 30 seconds.
Time frame: 12 months
New conduction disturbance
New left bundle-branch block, right bundle-branch block, first-degree atrioventricular block or other clinically relevant intraventricular conduction delay.
Time frame: 12 months
Severe bradycardia
Documented heart rate below 50 beats/min with symptoms, treatment or clinical concern; asymptomatic episodes will be described separately.
Time frame: 12 months
High-degree atrioventricular block
Mobitz II second-degree, advanced second-degree or complete atrioventricular block.
Time frame: 12 months
Permanent pacemaker implantation after day 7
New permanent pacemaker implantation not included in the primary endpoint. \>7 days to 30 days; \>30 days to 12 months
Time frame: 12 months
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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