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Recruiting NCT07342036

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

— Observational Tricuspid Valve Regurgitation Pacemaker ICD Left Bundle Branch Area Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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.

Primary outcome measures

  • Worsening of TR of at least 1 grade [Time frame: over the sutdy period up to 1 year after lead insertion]
Secondary outcome measures (3)
  • TR > mild at follow-up [Time frame: during study time frame up to 1 year after Pacemaker/ICD implantation]
  • NTproBNP change from baseline [Time frame: at 6 and at 12 months after Pacemaker/ICD implantation]
  • Hospitalization for heart failure (HFH) [Time frame: up to 12 months after Pacemaker/ICD implantation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Herz- und Diabeteszentrum NRW — Bad Oeynhausen

Identifiers

NCT: NCT07342036 · HDZ-KA_024_HO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗