Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHazem Omran
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 3 trial groupsSponsors and collaborators
Hazem Omran
Lead sponsor
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
Sponsor institution
Source ClinicalTrials.gov