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临床试验/NCT07617974
NCT07617974招募中不适用

Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)

Centro Cardiologico Monzino1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年5月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1

研究概览

简要总结

This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.

详细描述

Patients with paroxysmal or persistent AF undergoing transthoracic echocardiography (TTE) prior to AF ablation will be enrolled and will undergo repeat TTE at 1-year follow-up. The echocardiographic assessment will include standard measurements, right atrial and right ventricular strain analysis, and 3D acquisitions of the tricuspid valve (and mitral valve, if feasible). Tricuspid valve geometry will be analyzed using an AI-powered 3D quantification tool. AF burden will be assessed through serial Holter ECG monitoring at baseline, 3, and 12 months.

The primary endpoint is the difference in 3D tricuspid annular geometry between patients with paroxysmal and persistent AF. Secondary endpoints include interval changes in tricuspid annular geometry over one year, development of ≥ moderate TR, association between AF burden and tricuspid remodeling, identification of echocardiographic predictors of TR progression, and correlation between tricuspid and mitral valve changes.

Study results will be compared with two control groups: (1) subjects without AF and structurally normal hearts, and (2) patients with ≥ moderate atrial functional TR and AF, without significant left-sided valvular disease or prior valve interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.
  • Eligible for enrollment in the control group will be:
  • all consecutive patients with structurally normal hearts and no history of AF or;
  • moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.

排除标准

  • Moderate or greater TR assessed using a multiparametric approach;
  • Arrhythmias other than AF;
  • Prior AF ablations;
  • Rapid ventricular response (average HR >110 bpm) during baseline TTE;
  • Inadequate image quality

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Sponsor

研究点 (1)

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