Cardiology Research Dubrava Prospective Registry

Study Overview
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Brief Summary
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Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

Detailed Description
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Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy. In this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, NTproBNP values after specific interventions (in.ex. TAVI implantation, SGLT2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.

Official Title
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Cardiology Research Dubrava: Single Centre, Prospective Registry

Conditions
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Heart Failure, Arrhythmias, Cardiac, Atrial Fibrillation, Acute Coronary Syndrome

Intervention / Treatment
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* Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients implanted with CIED, or with VTE, or with ACS or with TAVI - Exclusion Criteria: non compliance, not undergoing follow-up at this center -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute coronary syndrome - ACS<br>patients who were diagnosed with acute coronary syndrome: STEMI, non-STE ACS - NSTEMI and unstable angina, who underwent coronary angiography and were prescribed with optimal medicament therapy | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,<br>* long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital<br>|
| Transcatheter aortic valve implantation - TAVI<br>patients with aortic stenosis who underwent transcatheter percotaneous implantation of the arteficial aortic valve | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,<br>* long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital<br>|
| Venous thromboembolism - VTE<br>patients with pulmonary embolism and deep vein thrombosis, with a focus on those who underwent thromboaspiration due to high or medium-high risk pulmonary embolism | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,<br>* long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital<br>|
| Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2<br>patients with heart failure with reduced, mid-reduced and preserved systolic function who were prescribed with a SGLT-2 inhibitor therapy, and other optimal medicament therapy for HF | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,<br>* long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital<br>|
| Cardiac implantable electronic device - CIED<br>patients who were implanted with a cardiac implantable electronic device: pacemaker, conduction system pacing device, cardioverter-defibrilator or cardiac resynchronization therapy with or without defibrilator option | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,<br>* long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death | death due to cardiovascular etiology during long term follow-up | 10 years | 
| freedom from atrial arrhythmias | Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up | 10 years | 
| Time to revascularization | Time to revascularization during acute coronary syndrome | 10 years | 
| Bleeding complications | Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy | 10 years | 
| Laboratory levels of NTproBNP | Laboratory levels of NTproBNP in patients with AFib after PVI, in patients with HF prescribed with SGLT2 inhibitors, in patients with ACS after complete revasculariazation, in patients implanted with CIED | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, acute coronary syndrome, SGLT-2 inhibitors, anticoagulants, atrial fibrillation, NTproBNP, cardiac implanted electronic device, observationl