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

N/ARecruitingNCT07342036

Hazem Omran200 enrolled

Overview

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.

The prevalence of tricuspid regurgitation (TR) in patients with a pacemaker or ICD/CRT device varies widely, ranging from 5% to 45% across different study protocols. To date, only retrospective analyses have shown that implantation of a device with a transvalvular lead can cause or worsen TR, highlighting the importance of early diagnosis. The aim of this study is to prospectively evaluate patients indicated for cardiac electronic device implantation to document the incidence of newly developed regurgitation (greater than trace) or worsening of existing regurgitation (by at least one grade). Additionally, the study will investigate predictive factors for the development or progression of TR.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Tricuspid Valve Regurgitation Pacemaker ICD Left Bundle Branch Area Pacing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * medically indicated for pacemaker, ICD- or CRT implantation * No previous diagnosis of severe tricuspid regurgitation on enrollment * No existing transvalvular device (must be first implantation) * No other diagnosed severe valvular heart disease * Not previous diagnosis with pre-capillary pulmonary hypertension * No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...) Exclusion Criteria: * Patients unable to give consent * Under the age of 18 years * Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo \>70 mmHg) * Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment * Patients who have undergone Lead-explantation * Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment. * Previous tricuspid valve surgery * Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...) * Pregnant or breastfeeding women * Life expectancy \< 12 months

Outcomes

Primary Outcomes

Worsening of TR of at least 1 grade

Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve

Time frame: over the sutdy period up to 1 year after lead insertion

Secondary Outcomes

TR > mild at follow-up

The percentage of patients with at least moderate TR or worse

Time frame: during study time frame up to 1 year after Pacemaker/ICD implantation

NTproBNP change from baseline

Change in NTproBNP levels from baseline to 6 and 12 Months

Time frame: at 6 and at 12 months after Pacemaker/ICD implantation

Hospitalization for heart failure (HFH)

Any uplanned hopsitalization with requirement of iv diuretics therapy after inclusion

Time frame: up to 12 months after Pacemaker/ICD implantation