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RecruitingNot ApplicableNCT07521800

Remote ECG Monitoring Post TAVI

Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.

Sponsor

Medical University of Silesia

Enrollment

250 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Remote MonitoringArrythmiaAtrioventricular BlockTAVI(Transcatheter Aortic Valve Implantation)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Remote ECG monitoring and a medical device called Standard Care (in control arm) for people with arrythmia, atrial fibrillation (af), and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemote 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).

DEVICEStandard 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

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NCT07521800

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