This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care. Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up. All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite advances in transcatheter heart valve technology and procedural techniques, conduction disturbances remain among the most frequent complications following TAVI. High-grade atrioventricular block, complete heart block, and new-onset bundle branch block may occur after the procedure and can lead to delayed permanent pacemaker implantation or life-threatening arrhythmic events. The increasing adoption of minimalist TAVI pathways with hospital discharge within 24-72 hours raises concerns that clinically significant arrhythmias may develop after discharge and remain undetected. Ambulatory electrocardiographic (ECG) monitoring provides continuous rhythm surveillance during daily activities and enables the early detection of both symptomatic and asymptomatic bradyarrhythmias and tachyarrhythmias. Previous observational studies have demonstrated that clinically significant bradyarrhythmias occur in approximately 5-10% of patients during the first weeks after TAVI, particularly among those with baseline or new-onset conduction abnormalities. Ambulatory ECG monitoring has also identified previously unrecognized atrial fibrillation, allowing timely initiation of anticoagulation therapy in patients at high risk of thromboembolic events. Although several prospective studies have evaluated ambulatory ECG monitoring after TAVI, most have been observational and were designed primarily to describe the incidence of post-procedural arrhythmias rather than to assess their impact on clinical outcomes. Preliminary evidence from the RECORD pilot study suggested that systematic ambulatory ECG monitoring after hospital discharge was associated with earlier identification and treatment of clinically significant arrhythmias and a reduction in the composite of sudden death, symptomatic arrhythmic events, and stroke during 1-year follow-up, with the greatest benefit observed among patients with conduction abnormalities at hospital discharge. This randomized trial has been designed to provide definitive evidence regarding the clinical value of systematic ambulatory ECG monitoring after TAVI in patients at increased risk of post-procedural conduction disturbances. The study will evaluate whether early detection and management of clinically significant arrhythmias can improve clinical outcomes during the year following the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
754
Participants randomized to the intervention arm will undergo systematic ambulatory ECG monitoring at hospital discharge following the TAVI procedure. A wearable ambulatory ECG monitoring device will be applied for continuous rhythm monitoring during a 14-day period. The device will allow detection of clinically significant bradyarrhythmias and tachyarrhythmias. Detected arrhythmic events will be reviewed by the study team, and appropriate clinical management, including further evaluation or therapeutic intervention, will be performed according to the nature of the detected abnormality and standard clinical practice.
Institut universitaire de cardiologie et de pneumologie de Québec - UL
Québec, Quebec, Canada
Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
Time frame: Within the year following the TAVI procedure
Incidence of sudden death
Sudden death
Time frame: 1 year after TAVI
Incidence of symptomatic arrhythmias
All symptomatic arrhythmias events
Time frame: 1 year after TAVI
Incidence of stroke
All stroke events
Time frame: 1 year after TAVI
Incidence of PPI
Number of patients with PPI
Time frame: 30 days after TAVI
Incidence of PPI
Number of patients with PPI
Time frame: 1 year after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
Time frame: 30 days after TAVI
Incidence of sudden death
Sudden death
Time frame: 30 days after TAVI
Incidence of symptomatic arrhytmias
All symptomatic arrhythmias events
Time frame: 30 days after TAVI
Incidence of stroke
All stroke events
Time frame: 30 days after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to patient sex.
Time frame: 1 year after TAVI
Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to ECG abnormality status (pre-existing versus new-onset after TAVI).
Time frame: 1 year after TAVI
Incidence of the combined endpoint according to baseline ECG abnormality type
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) analyzed according to the type of ECG abnormality present before TAVI.
Time frame: 1 year after TAVI
Incidence of sudden death according to baseline ECG abnormality type
Sudden death analyzed according to the type of ECG abnormality present before TAVI.
Time frame: 1 year after TAVI
Incidence of symptomatic arrhythmias according to baseline ECG abnormality type
Symptomatic arrhythmias according to the type of ECG abnormality present before TAVI.
Time frame: 1 year after TAVI
Incidence of stroke according to baseline ECG abnormality type
Stroke according to the type of ECG abnormality present before TAVI.
Time frame: 1 year after TAVI
Incidence of the combined endpoint according to discharge ECG abnormality type
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) according to the type of ECG abnormality present at hospital discharge.
Time frame: 1 year after TAVI
Incidence of sudden death according to discharge ECG abnormality type
Sudden death according to the type of ECG abnormality present at hospital discharge.
Time frame: 1 year after TAVI
Incidence of symptomatic arrhythmias according to discharge ECG abnormality type
Symptomatic arrhythmias according to the type of ECG abnormality present at hospital discharge.
Time frame: 1 year after TAVI
Incidence of stroke according to discharge ECG abnormality type
Stroke according to the type of ECG abnormality present at hospital discharge.
Time frame: 1 year after TAVI
Change in quality of life
Quality of life assessed using the EQ-5D-5L questionnaire.
Time frame: Baseline to 1 year after TAVI
Percentage of ventricular pacing
Ventricular pacing burden in participants with permanent pacemakers.
Time frame: 1 year after TAVI
Incidence of all-cause mortality
All-cause mortality
Time frame: 30 days after TAVI
Incidence of cardiovascular mortality
Cardiovascular mortality
Time frame: 30 days after TAVI
Incidence of all-cause mortality
All cause mortality
Time frame: 1 year after TAVI
Incidence of cardiovasculare mortality
Cardiovascular mortality
Time frame: 1 year after TAVI
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