Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · NCT07342036
This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW (other) |
| Locations | 1 site (Bad Oeynhausen, North Rhine-Westphalia) |
| Trial ID | NCT07342036 on ClinicalTrials.gov |
What this trial studies
This prospective observational project will enroll adults scheduled for first-time transvenous pacemaker, ICD, or CRT implantation and perform detailed transthoracic echocardiography with 3D tricuspid imaging before and after device placement. Participants will have routine follow-ups at 6 and 12 months with repeat TTE, ECG, NT-proBNP measurement, and device checks to document any change in tricuspid regurgitation. The primary outcome is the incidence of newly developed or worsened TR (greater than trace or increase by at least one grade), and secondary analyses will explore predictors of TR progression. Results aim to clarify how often and when lead-associated TR occurs and which factors increase risk.
Who should consider this trial
Good fit: Adults medically indicated for first-time pacemaker, ICD, or CRT implantation who do not have severe tricuspid regurgitation, significant other valvular disease, pre-capillary pulmonary hypertension, or structural right ventricular disease are ideal candidates.
Not a fit: Patients with prior transvenous leads, prior tricuspid valve surgery, existing severe TR, congenital heart disease affecting the valve, inability to consent, or who cannot attend center follow-ups are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, the findings could enable earlier detection of lead-associated TR and lead to changes in implantation technique or follow-up that reduce valve damage.
How similar studies have performed: Retrospective analyses have reported associations between transvalvular leads and worsening TR, but prospective data are limited, making this prospective documentation relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bad Oeynhausen, North Rhine-Westphalia
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Principal investigator: Hazem Omran, MD — Herz- und Diabeteszentrum NRW
- Study coordinator: Hazem Omran, MD
- Email: homran@hdz-nrw.de
- Phone: +49 5731 970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing, tricuspid regurgitation, lead-related TR, lead-associated TR