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

NCT ID: NCT07342036

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2027-01-30

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.

Conditions

Tricuspid Valve Regurgitation; Pacemaker; ICD; Left Bundle Branch Area Pacing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pacemaker-standard

Only pacemaker with standard positioning (no ICD leads, no LBBaP)

No interventions assigned to this group

ICD

any ICD leads through tricuspid valve

No interventions assigned to this group

LBBaP

Left bundle branch area pacing leads

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hazem Omran

OTHER

Sponsor Role: lead

Responsible Party

Hazem Omran

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hazem Omran, MD

Role: PRINCIPAL_INVESTIGATOR

Herz- und Diabeteszentrum NRW

Locations

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Hazem Omran, MD

Role: CONTACT

homran@hdz-nrw.de

+49 5731 970

Lena Riemke-Maw, BSc

Role: CONTACT

lriemke-maw@hdz-nrw.de

+49 5731 97 ext. 1258

Facility Contacts

Hazem Omran, MD

Role: primary

homran@hdz-nrw.de

+49 5731 972

Lena Riemke-Maw, BSc

Role: backup

lriemke-maw@hdz-nrw.de

+49 5731 970

Other Identifiers

HDZ-KA_024_HO

Identifier Type: -

Identifier Source: org_study_id