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

NCT07342036 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Hazem Omran

    lead OTHER

Principal Investigators

  • Hazem Omran, MD · Herz- und Diabeteszentrum NRW

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2027-01-01
Completion
2027-01-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342036 on ClinicalTrials.gov