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

250 Participants
are divided into 2 treatment groups

Locations

4
Italy
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza Turin Italy
Poland
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland Bialystok Poland
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland40-635, Katowice Poland
Medical University of Silesia40-055, Katowice Poland

Sponsors and collaborators

Medical University of Silesia

Lead sponsor