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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.

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.

Disqualifiers

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;

Trial population

Patients suitable for enrolment in the present study are those with paroxysmal or persistent atrial fibrillation (AF) undergoing transthoracic echocardiography (TTE) prior to AF ablation and will be study group. The study group will be compared with the following control groups: a) patients with structurally normal hearts and no history of AF; b) patients with ≥ moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

66 Participants
are grouped into 2 trial groups
Group A: Prospective Cohort
Group B: Control group

Trial outcomes

Primary outcomes

1

Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation

Time frame
12 months

Secondary outcomes

1

Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography

Time frame
over 12 months
2

Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography

Time frame
12 months
3

Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)

Time frame
12 months
4

Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation

Time frame
12 months

Other outcomes

Sponsors and contacts

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Centro Cardiologico Monzino

Lead sponsor

Istituto Clinico Humanitas

Collaborator