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.
Medical University of Silesia
250 participants
Dec 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
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).
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07521800