NCT07521800

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	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).
DEVICE	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).

Timeline

• Start date: 2023-12-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

4 sites across 2 countries: Italy, Poland