NIPH Clinical Trials Search

Tricuspid Regurgitation Registry Study Using Artificial Intelligence Technology

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Tricuspid valve regurgitation
Date of first enrollment	01/01/2014
Target sample size	5000
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Composite endpoint consisting of all-cause mortality and hospitalization for heart failure occurring at 30 days, 1 year, and during annual follow-up periods stratified by TR severity.

Secondary Outcome

1.Clinical Events Clinical events at 30 days, 1 year, and annually thereafter All-cause mortality (cardiovascular and non-cardiovascular death) All hospitalizations (heart failure, cardiovascular, and non-cardiovascular hospitalizations) Myocardial infarction Stroke Initiation of renal replacement therapy Bleeding Surgical/catheter-based interventions New pacemaker implantation 2. Echocardiography Parameters 3.Validation of the accuracy of ultrasound image analysis software Us2.ai

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Cases diagnosed with Severe TR who underwent transthoracic echocardiography (TTE) at the University of the Ryukyus, Okinawa Prefectural Chubu Hospital, or Naha City Hospital between January 1, 2014, and December 31, 2023 (Mild/Moderate TR Group) Cases diagnosed with Mild or Moderate TR who underwent transthoracic echocardiography (TTE) two or more times at the University of the Ryukyus, Okinawa Prefectural Chubu Hospital, or Naha City Hospital between January 1, 2014, and December 31, 2023
Exclude criteria	(Severe TR Group) 1. Echocardiographic images are not suitable for AI analysis. 2. Age at the time of the first TTE was under 18 years. (Mild/Moderate TR Group) 1. Echocardiographic images are not suitable for AI analysis. 2. Age at the time of the first TTE was under 18 years.