Health Trials

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 groups

Locations

1
Herz- und Diabeteszentrum NRW32545, Bad OeynhausenNorth Rhine-Westphalia, Germany

Sponsors and collaborators

Hazem Omran

Lead sponsor

Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW

Sponsor institution

Source ClinicalTrials.gov