Remote ECG Monitoring Post TAVI
Recruiting · NCT07521800 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Silesia
View the official record on ClinicalTrials.gov →Interventions studied
Remote ECG monitoringStandard Care (in control arm)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- 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
- Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza - Turin, Italy