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3D Transthoracic ECHOcardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients with Cardiac Implantable Electronic Device

3D Transthoracic ECHOcardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients with Cardiac Implantable Electronic Device

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011605
Enrollment
1000
Registered
2026-02-11
Start date
2026-01-22
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 19 years or older. 2. Patients who are at least one year post-implantation of one of the following Cardiac Implantable Electronic Devices (CIEDs), specifically involving either a leadless pacemaker or a device with leads crossing the tricuspid annulus: A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker 3. Patients who underwent the implantation procedure on or after January 2022. 4. Voluntary informed consent provided by the patient or their legal representative for the review of medical records and study-related data throughout the entire study period.

Exclusion criteria

Exclusion criteria: 1. Patients with lead-based CIEDs whose leads do not cross the tricuspid annulus or those with two or more leads crossing the annulus. 2. Patients whose baseline degree of tricuspid regurgitation (TR) cannot be assessed due to the absence of transthoracic echocardiography (TTE) performed within three months of the procedure. 3. Patients with a history of ventricular lead extraction. 4. Patients who have undergone tricuspid valve replacement surgery. 5. Women who are pregnant or breastfeeding. 6. Individuals who refuse active medical treatment.

Design outcomes

Primary

MeasureTime frame
hospitalization due to heart failure—

Secondary

MeasureTime frame
incidence of CIED related, associated TR;hospitalization due to heart failure;re-admission;IV furosemide infusion;Tricuspid valve intervention;transvenous lead extraction or reposition;eGFR by CKD-EPI and MDRD equation;occurrence of chronic kidney disease;renal replacement therapy;Child Pugh score;NTproBNP;functional status;echocardiographic parameters;ECG parameter;Average heart rate and heart rate distribution;pacing burden;AT/AF occurrence and burden—

Countries

Korea, Republic of

Contacts

Public ContactJuwon Kim

Samsung Medical Center

abcd186a@naver.com+82-2-3410-2578

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026