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Remote ECG Monitoring Post TAVI
Sponsor: Medical University of Silesia
Summary
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.
Official title: Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2023-12-01
Completion Date
2028-02-01
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Remote ECG monitoring
Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the 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).
Standard Care (in control arm)
Description: Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the 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).
Locations (4)
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