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NCT06914570: CIED-REMTRIC

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

Recruiting now Last updated 6 April 2025
What this trial tests

trial in Cardiac Pacing, Artificial in 350 participants. Currently enrolling.

Timeline
1 May 2024
Primary endpoint
1 May 2026
24 February 2029

Quick facts

Lead sponsorIstituto Auxologico Italiano
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment350
Start date1 May 2024
Primary completion1 May 2026
Estimated completion24 February 2029
Sites1 location across Italy

Conditions studied

Sponsor

Istituto Auxologico Italiano — full company profile →

Who can join

18 and older, any sex, with Cardiac Pacing, Artificial or Tricuspid Valve Regurgitation, Non-rheumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Istituto Auxologico Italiano trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06914570.

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