Remote ECG Monitoring Post TAVI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Silesia

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

Sponsors and collaborators