The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.
Patient age over 18 years old
Severe aortic stenosis
Moderate or high cardiovascular risk based on current ESC Guidelines "Heart Team" qualification for TAVI
Written informed consent of the patient for participation in the study
History of atrial fibrillation or atrial flutter
Previously known conduction disturbances**
Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI
Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification
Crossover
Remote ECG monitoring
DevicePatients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the control group (which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days).
Standard Care (in control arm)
DeviceDescription: Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the control group (which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days).
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
Secondary endpoints will include: All-cause mortality; Major composite adverse cardiovascular events (MACEs, ie, cardiovascular death, stroke, myocardial infarction, hospitalisation for heart failure); Episodes of syncope; cardiac arrhythmias
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