AMJ-504 Japan Trial

JRCT ID: jRCT2072210125

Registered date:11/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Tricuspid valve regurgitation
• Date of first enrollment: 28/09/2021
• Target sample size: 35
• Study type: Interventional
• Intervention(s): The treatment of patients with symptomatic, severe tricuspid valve regurgitation, whose symptoms and TR severity persist despite being optimally treated with medical therapy.

Outcome(s)

Primary Outcome

The primary endpoint is a composite endpoint of freedom from all-cause mortality or need for tricuspid valve surgery at 12 months.
The co-primary endpoint is annualized HF hospitalization (HFH) rate within 12 months after AMJ-504 procedure.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
- Optimized medical therapy for treatment of TR (e.g. diuretics)
- Medical and-or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure
2.Subject is symptomatic with severe TR despite being optimally treated as described in (1). TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
3.The cardiac surgeon of the site local heart team concur that the patient is not optimal for tricuspid valve surgery.
4.New York Heart Association (NYHA) Functional Class 2, 3 or ambulatory class 4

Exclude criteria

1. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of qeual or more than 1.0 cm2 and-or mean gradient equal or more than 5 mmHg as measured by the ECL
2. LVEF equal or less than 20%
3. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
a.Evidence of calcification in the grasping area
b. Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
c.Severe leaflet defect(s) preventing proper device placement
d.Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.

Related Information

• Primary Sponsor: Junya Ako