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

ConditionsTricuspid Valve RegurgitationPacemakerICDLeft Bundle Branch Area Pacing
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

This trial does not accept healthy volunteers

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 population

patients who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: Pacemaker-standard
Group B: ICD
Group C: LBBaP

Trial outcomes

Primary outcomes

1

Worsening of TR of at least 1 grade

Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve

Time frame
over the sutdy period up to 1 year after lead insertion

Secondary outcomes

1

TR > mild at follow-up

The percentage of patients with at least moderate TR or worse

Time frame
during study time frame up to 1 year after Pacemaker/ICD implantation
2

NTproBNP change from baseline

Change in NTproBNP levels from baseline to 6 and 12 Months

Time frame
at 6 and at 12 months after Pacemaker/ICD implantation
3

Hospitalization for heart failure (HFH)

Any uplanned hopsitalization with requirement of iv diuretics therapy after inclusion

Time frame
up to 12 months after Pacemaker/ICD implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hazem Omran

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov
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