Clinical Trials Logo

Clinical Trial Summary

The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.


Clinical Trial Description

Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable. This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05724225
Study type Observational [Patient Registry]
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Active, not recruiting
Phase
Start date October 6, 2021
Completion date December 29, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06196684 - Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
Not yet recruiting NCT03278418 - Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach N/A
Terminated NCT03632967 - Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System N/A
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Completed NCT01444222 - Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Completed NCT04945005 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Recruiting NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) N/A
Completed NCT01585779 - Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial N/A
Withdrawn NCT03166488 - MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair N/A
Completed NCT03604484 - Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery N/A
Completed NCT01537458 - Long-term Outcome After Isolated Tricuspid Valve Repair
Recruiting NCT05913908 - EFS of the DUO System for Tricuspid Regurgitation (TANDEM II) N/A
Recruiting NCT04436653 - THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve N/A
Completed NCT01334801 - Biomarkers in Aortic Stenosis - B.A.S.S.
Recruiting NCT04735003 - Transcatheter Interventions for Tricuspid Insufficiency in Italy
Recruiting NCT02314897 - Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study N/A
Completed NCT01532921 - EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Active, not recruiting NCT04614402 - Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System