None listed
Conditions
Interventions
None listed
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =19 years. 2. Patients undergoing first-time (de novo) implantation of at least one of the following cardiac implantable electronic devices (CIEDs): A. Permanent pacemaker B. Implantable cardioverter-defibrillator (ICD) C. Cardiac resynchronization therapy (CRT) device D. Implantable loop recorder E. Leadless pacemaker 3. Patients or their legally authorized representatives who voluntarily provide consent for access to medical records and collection of study-related data throughout the entire study period.
Exclusion criteria
Exclusion criteria: 1. Patients with any pre-existing right-sided intracardiac lead or a previously implanted CIED other than an implantable loop recorder. 2. Patients with massive or torrential tricuspid regurgitation documented on prior imaging studies. 3. Patients with a mechanical prosthetic heart valve. 4. Patients with a life expectancy of less than 1 year due to non-cardiac or cardiac comorbidities. 5. Pregnant or breastfeeding women. 6. Patients who refuse active treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of all-cause mortality and hospitalization due to heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of CIED related, associated TR;All-cause mortality;Cardiac mortality;hospitalization due to heart failure;re-admission due to any cause;tricuspid valve intervention;transvenous lead extraction or reposition;eGFR by CKD-EPISODE and MDRD equation;renal replacement therapy;Child Pugh score;NT-proBNP;functional status;Echocardiographic parameters;ECG parameters;average heart rate, heart rate distribution;Pacing burden;AF occurrence and burden;AT occurrence and burden;Procedure-related complications | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Ji Park
Samsung Medical Center
Outcome results
None listed