In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
ASTRA
ASTRA
Sponsor study identifier
observational
1,050
1 country
2
Study Start
December 2, 2022
Actual (reported)Primary Completion
December 2, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2022
Actual (reported)February 18, 2023
Actual (reported)March 1, 2023
Actual (reported)December 2, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of either moderate or severe functional tricuspid regurgitation
To assess the prevalence of moderate or severe atriogenic secondary tricuspid regurgitation (STR) in patients with persistent/permanent atrial fibrillation (AF), and to develop valve-specific metrics and parameters to assess STR severity by echocardiography.
1 year
To identify the mechanisms leading to moderate/severe STR during AF.
STR severity varies among patients with persistent/permanent AF and comparable RV and RA remodeling. The role of RV and RA size, shape, and function on the extent of tricuspid annulus dilation and dysfunction remains to be clarified. Moreover, it is unknown whether the leaflets of the tricuspid valve can adapt to the stretch exerted on them by the progressive dilation of the tricuspid annulus. The contribution of leaflet adaptation to the pathophysiology of STR and its molecular determinants remains to be clarified
3 years
To evaluate the extent of the right heart structure remodeling occurring after the recovery of the sinus rhythm and its effects on STR severity.
Patients undergoing sustained cardioversion to sinus rhythm (both electrical and pharmacological) and/or ablation of AF, will be followed at 1, 3, and 12 months after the procedure by recording electrocardiogram and complete 2D Doppler and 3DE to assess the extent of the remodeling of the RV, the RA, and the tricuspid valve apparatus. Patients with atriogenic moderate/severe STR without clinical indication to either cardioversion or ablation of the AF, and patients with none/mild atriogenic STR will be followed with clinical assessment, and complete 2D, Doppler and 3DE at 6 months and 1 year. The severity of STR will be quantified by measuring EROA, regurgitant volume, and regurgitant fraction.
Development of an interpretable predictive model by using and integrating a variety of statistical and artificial intelligence (AI) techniques.
3 years
Patients with persistent/permanent atrial fibrillation and any degree of isolated tricuspid regurgitation
Identify AF patients at risk of developing moderate/severe STR and those who will benefit from restoring the normal sinus rhythm
To identify the mechanisms leading to moderate/severe STR during AF.
Patients undergoing echocardiography stud because of persistent/permanent atrial fibrillation
Istituto Auxologico Italiano, IRCCS
Milan, Select A State, 20149, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Serum and plasma specimen for proteomic and miRNA analyses
First Submitted
February 18, 2023
First Posted
March 1, 2023
Study Start
December 2, 2022
Actual (reported)Primary Completion
December 2, 2024
Estimated (date passed)Patient-TAILORed Ablation of Persistent AF Guided by Instantaneous Amplitude and Frequency Modulation Maps (TAILOR-AF)
3 years
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 15, 2024
Record last verified: 2024-03
Data will be made available upon reasonable request
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Source: ClinicalTrials.gov.
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