ICD, Left Bundle Branch Area Pacing, Pacemaker, Tricuspid Valve Regurgitation
Conditions
Keywords
tricuspid regurgitation, lead-related TR, lead-associated TR
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Hazem Omran
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worsening of TR of at least 1 grade | over the sutdy period up to 1 year after lead insertion | Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TR > mild at follow-up | during study time frame up to 1 year after Pacemaker/ICD implantation | The percentage of patients with at least moderate TR or worse |
| NTproBNP change from baseline | at 6 and at 12 months after Pacemaker/ICD implantation | Change in NTproBNP levels from baseline to 6 and 12 Months |
| Hospitalization for heart failure (HFH) | up to 12 months after Pacemaker/ICD implantation | Any uplanned hopsitalization with requirement of iv diuretics therapy after inclusion |
Countries
Germany
Contacts
Primary ContactHazem Omran, MD
Backup ContactLena Riemke-Maw, BSc
Outcome results
None listed