NCT07793916 3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
| NCT ID | NCT07793916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Tricuspid Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-22 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs). The main objective is to compare left bundle branch area pacing (LBBaP) and leadless pacemakers against conventional pacemakers in terms of TR exacerbation. Participants with these devices will have their retrospective and prospective clinical data analyzed and will undergo 3D transthoracic echocardiography to identify the exact mechanical causes of TR.
Eligibility Criteria
Inclusion Criteria: * Aged 19 years or older. * Patients who are at least one year post-implantation of one of the following Cardiac Implantable Electronic Devices (CIEDs): A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker * Patients who underwent the implantation procedure on or after January 2022. * 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: * Patients with lead-based CIEDs whose leads do not cross the tricuspid annulus or those with two or more leads crossing the annulus. * 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. * Patients with a history of ventricular lead extraction. * Patients who have undergone tricuspid valve replacement surgery. * Individuals who refuse active medical treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07793916 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07793916 currently recruiting?
Yes, NCT07793916 is actively recruiting participants. Contact the research team at abcd186a@naver.com for enrollment information.
Where is the NCT07793916 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07793916 clinical trial?
NCT07793916 is sponsored by Samsung Medical Center. The trial plans to enroll 1,000 participants.