Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Auxologico Italiano
About this trial
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging.
The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation.
Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years.
They can be summarized as follows:
1. to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation. 2. to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level. 3. to determine the clinical impact of new or worsening TR after CIED implantation. 4. to explore the treatment strategies for lead-related TR (observational).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patient able and willing to give informed consent in written form before the index procedure
Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
Patients undergoing any new CIED implantation with or without transvalvular lead
Disqualifiers
Previous or present CIED
Life expectancy < 12 months due to non-cardiac condition
Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
Previous tricuspid valve intervention (transcatheter, surgical)
Trial population
Patients undergoing new implantation of a CIED
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: CIED
Trial outcomes
Primary outcomes
1
Change in TR at least one grade after new CIED implantation
TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.
Time frame
5 yearsSecondary outcomes
1
Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)
Time frame
5 years2
Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics
Time frame
1 year, and annually through 5 years3
New York Heart Association (NYHA) functional class
Time frame
at 1 day, 3 months, 1 year, and annually through 5 years4
Incidence of tricuspid valve intervention (either transcatheter or surgical)
Time frame
1 year, and annually through 5 yearsSponsors and contacts
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Source ClinicalTrials.gov