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

March 31, 2025 updated by: Istituto Auxologico Italiano

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20149
        • Recruiting
        • San Luca Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Samantha Fisicaro, RCDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing new implantation of a CIED

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CIED

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)
Time Frame: 5 years
5 years
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
1 year, and annually through 5 years
New York Heart Association (NYHA) functional class
Time Frame: at 1 day, 3 months, 1 year, and annually through 5 years
at 1 day, 3 months, 1 year, and annually through 5 years
Incidence of tricuspid valve intervention (either transcatheter or surgical)
Time Frame: 1 year, and annually through 5 years
1 year, and annually through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Luigi Badano, MD, Ph.D., Istituto Auxologico Italiano, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

February 24, 2029

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Depends on subscription of a Data transfer agreement

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

Researchers who are members of Institutions who will subscribe a data transfer agreement for this specific study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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