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Remote ECG Monitoring Post TAVI

Remote ECG Monitoring Post TAVI

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Haemorrhagic stroke within 1 year before TAVI qualification
  • Chronic immunosuppressive therapy
  • Comorbidities (e.g. drug addiction, alcohol abuse, emotional/mental disorders) which do not allow safe participation in the study

Study details
    TAVI(Transcatheter Aortic Valve Implantation)
    Remote Monitoring
    Arrythmia
    Atrial Fibrillation (AF)
    Atrioventricular Block

NCT07521800

Medical University of Silesia

13 May 2026

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