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Remote ECG Monitoring Post TAVI

RecruitingNAAges 18 Years - anyAllMedical University of Silesia
NCT07521800 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Remote ECG monitoring
  • Standard Care (in control arm)
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Where

4 sites
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza
Turin, Italy
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland
Bialystok, Poland
Medical University of Silesia
Katowice, Poland
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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