Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion

The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.

NCT Number	NCT07342036
Lead Sponsor	Hazem Omran
Conditions	Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing
Enrollment	200 participants
Start Date	2024-07-19
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-16