About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Remote ECG monitoring
- Standard Care (in control arm)
Treatment groups
Locations
4Sponsors and collaborators
Medical University of Silesia
Lead sponsor