Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers (CIED-REMTRIC)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Cardiac Pacing, Artificial; Tricuspid Valve Regurgitation, Non-rheumatic

Study type: Observational

Funder types: Other

Identifiers

NCT06914570

09C407

Details and patient eligibility

About

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).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers

Exclusion criteria

• 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)
• Participation in another study, which would lead to deviations from this trial protocol

Trial design

350 participants in 1 patient group

CIED

Description:

Patients undergoing new implantation of a CIED Inclusion criteria * Age ≥ 18 years * Patient is able and willing to give informed consent in written form before the index procedure * Patient understands the purpose, the potential risks and the 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 * Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers Exclusion criteria * 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)