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

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Valve Regurgitation; Pacemaker; ICD; Left Bundle Branch Area Pacing

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hazem Omran, MD; Phone Number: +49 5731 970; Email: homran@hdz-nrw.de
• Study Contact Backup: Name: Lena Riemke-Maw, BSc; Phone Number: 1258 +49 5731 97; Email: lriemke-maw@hdz-nrw.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
      • Recruiting
      • Herz- und Diabeteszentrum NRW
      • Contact: Hazem Omran, MD; Phone Number: +49 5731 972; Email: homran@hdz-nrw.de
      • Contact: Lena Riemke-Maw, BSc; Phone Number: +49 5731 970; Email: lriemke-maw@hdz-nrw.de
      • Principal Investigator: Hazem Omran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Pacemaker-standard; Only pacemaker with standard positioning (no ICD leads, no LBBaP)
ICD; any ICD leads through tricuspid valve
LBBaP; Left bundle branch area pacing leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	over the sutdy period up to 1 year after lead insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TR > mild at follow-up	The percentage of patients with at least moderate TR or worse	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	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	up to 12 months after Pacemaker/ICD implantation

Collaborators and Investigators

• Sponsor: Hazem Omran
• Investigators: Principal Investigator: Hazem Omran, MD, Herz- und Diabeteszentrum NRW

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Estimated): January 15, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: tricuspid regurgitation; lead-related TR; lead-associated TR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: HDZ-KA_024_HO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No