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

Recruiting

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

• Registration Number: NCT06914570
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-05-01
• Study Completion: 2029-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in TR at least one grade after new CIED implantation	5 years	TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.

Secondary Outcome Measures

Name	Time	Method
Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)	5 years
Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics	1 year, and annually through 5 years
New York Heart Association (NYHA) functional class	at 1 day, 3 months, 1 year, and annually through 5 years
Incidence of tricuspid valve intervention (either transcatheter or surgical)	1 year, and annually through 5 years

Trial Locations

Locations (1)

San Luca Hospital; 🇮🇹 Milan, MI, Italy