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
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza
RECRUITING
Turin
Poland
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland
RECRUITING
Bialystok
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
NOT_YET_RECRUITING
Katowice
Medical University of Silesia
RECRUITING
Katowice
Contact Information
Primary
Wojciech Wańha, MD, PhD
wojciech.wanha@gmail.com
504827636
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 250
Treatments
Experimental: Remote ECG monitoring
Device: continuous 30-day ECG monitoring with visits triggered by ECG findings
Active_comparator: Standard care
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
Related Therapeutic Areas
Sponsors
Leads: Medical University of Silesia