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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2029-02-24

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Pacing, Artificial Tricuspid Valve Regurgitation, Non-rheumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No