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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ECG monitoring | Experimental | Device: continuous 30-day ECG monitoring with visits triggered by ECG findings |
|
| Standard care | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ECG monitoring | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints will include: All-cause mortality; Major composite adverse cardiovascular events (MACEs, ie, cardiovascular death, stroke, myocardial infarction, hospitalisation for heart failure); Episodes of syncope; cardiac arrhythmias | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wojciech Wańha, MD, PhD | Contact | 504827636 | wojciech.wanha@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza | Recruiting | Turin | Italy |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard Care (in control arm) | Device | 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). |
|
| Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland | Recruiting | Bialystok | Poland |
|
| Medical University of Silesia | Recruiting | Katowice | 40-055 | Poland |
|
| Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland | Not yet recruiting | Katowice | 40-635 | Poland |
|
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |