Transcatheter tricuspid valve repair (Trialign) in treating secondary tricuspid regurgitation

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063888

Enrollment

Unknown

Registered

2022-09-20

Start date

2022-09-20

Completion date

Unknown

Last updated

2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tricuspid regurgitation

Interventions

Intervention Group:Transcatheter tricuspid valve repair (Trialign)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Able to provide informed consent 2.Age =18 years old and =85 years old 3.NYHA Class function is II, III or IV in ambulating patients 4.Moderate or severe secondary tricuspid regurgitation 5.High surgical risk 6.Echocardiography: a)pulmonary systolic pressure=60mmHg; b)LVEF=30%; c)TAPSE= 15mm; d) Tricuspid annular diameter= 15mm (4-chamber view);e)effective regurgitant orifice areaA=1.75cm2;f)secondary TR with normal annulus anatomy 7.Dimensions of the septal annulus suitable for device implantion

Exclusion criteria

Exclusion criteria: 1.Severe hypertension(systolic BP=180mmHg, and/or diastolic BP=110mmHg) 2.prior history of heart transplantation 3.prior history of surgical tricuspid valve repair/replacement 4.concomittant LVAD 5.Acute infective endocarditis 6.severe degenerative tricuspid valve disease 7.severe aortic stenosis 8.mitral regurgitation >3+ 9.chronic total occlusion (CTO) of the right coronary artery 10.occlusion or thrombus in right internal jugular vein 11.Vascualr access or its adjacent anatomy unsuitable for device implantation 12. Right heart thrombus 13. history of unstable angina within 30 days of evaluation 14.history of PCI within 30 days of evaluation or PCI planned within 3 months after evaluation 15.Unstable hemodynamics or cardiogenic shock 16.restrictive or hypertrophic cardiomyopathy, structural pericarditid or any other strucutual heart disease 17.history of stroke within 6 months of evaluation 18.severe renal deficiency(eGFR=30ml/min); creatinine>2.5mg/dl(221µmol/L) 19.severe anemia not improved by transfusion (hemoglobulin750×109/L 20. bleeding diathesis 21.active GI ulcers or bleeding 22.contraindications for anticoagulation or antiplatelet therapy 23.contraindications for transfusion or refusal of transfusion 24.allergic to metal components or contrast dye 25.pregnency or planning of pregnency during the procedure 26.life expectancy < 1 year 27.Use of other clinical trial device at the same time or 30 days prior to enrollment 28.other contraindications of the procedure

Design outcomes

Primary

Measure	Time frame
all-cause mortality;	—

Countries

China

Contacts

Public ContactMao Chen

West China Hospital, Sichuan University

hmaochen@vip.sina.com18980602046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026