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.

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.

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