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NCT Number: NCT06914570

Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers

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).

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Key information

Conditions

Cardiac Pacing, Artificial Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency Tricuspid Valve Regurgitation, Non-rheumatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in TR at least one grade after new CIED implantation

    Time frame: 5 years

    TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.

Secondary outcomes

  1. Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)

    Time frame: 5 years

  2. Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics

    Time frame: 1 year, and annually through 5 years

  3. New York Heart Association (NYHA) functional class

    Time frame: at 1 day, 3 months, 1 year, and annually through 5 years

  4. Incidence of tricuspid valve intervention (either transcatheter or surgical)

    Time frame: 1 year, and annually through 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi P Badano, MD, Ph.D.

CONTACT

[email protected]

+3902619112319

Michele Tomaselli, MD, Ph.D.

CONTACT

[email protected]

02619112648

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: CIED-REMTRIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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