Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)

NCT04936802 | Unknown

• 1 other identifier: Trialign study
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Severe adverse device events (SADE)

  Severe adverse device events (SADE) , defined as any device related complication, including but not limited to: death, myocardial infarction, stroke, reoperation, renal failure, pulmonary embolism, gastrointestinal bleeding, readmission, etc.

  30 days

Secondary Outcomes (6)

• Technical success

  30 days

• Evaluation of tricuspid valve function

  6 months

• New York Heart Association (NYHA) classification

  6 months

• 6-minute walk test (6MWT)

  6 months

• EuroQol five dimensions questionnaire (EQ-5D)

  6 months

Study Arms (1)

Transcatheter tricuspid valve repair system (Trialign)

EXPERIMENTAL

Subjects who received transcatheter tricuspid valve repair with Trialign will be included in this arm.

Device: Transcatheter tricuspid valve repair system (Trialign)

Interventions

Transcatheter tricuspid valve repair system (Trialign) DEVICE

To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation

Transcatheter tricuspid valve repair system (Trialign)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects has been informed the study and provided written informed consent.
• Age ≥ 18 and ≤ 85 years old.
• NYHA class II, III or ambulatory IV.
• The subject was diagnosed moderate to severe functional tricuspid regurgitation
• The subject was at high risk for open heart valve surgery. The heart team recommended tricuspid annuloplasty.
• Subjects shall meet all selected criteria for TEE with moderate or severe tricuspid regurgitation.
• Systolic pulmonary artery pressure (SPAP) ≤ 60mmHg.
• Left ventricular ejection fraction (LVEF) ≥ 30%.
• Right ventricle tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm.
• Tricuspid valve annular diameter ≤ 55 mm.
• Tricuspid EROA ≤ 1.75 cm2.
• Functional tricuspid valve regurgitation pathology with a structurally normal valve.
• Sufficient posterior annular dimension for device implantation.

You may not qualify if:

• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg).
• History of heart transplant.
• Previous tricuspid valve repair or replacement (including artificial valve).
• Presence of a left ventricular assist device.
• Active endocarditis.
• Severe degenerative tricuspid valve disease.
• Severe aortic stenosis.
• The degree of mitral regurgitation is greater than grade 3.
• Complete occlusion due to chronic calcification of the right coronary artery.
• History of right internal jugular vein occlusion or thrombosis;
• Anatomy in the region of the access path (right internal jugular vein) prevented correct placement of a percutaneous tricuspid valve annuloplasty system (e.g.: the presence of spinal stenosis, stent, vascular prosthesis).
• An indication of the presence of thrombi in the right ventricle or atrium.
• Myocardial infarction (MI) or known unstable angina within the 30 days prior to the index procedure.
• Any percutaneous coronary intervention (PCI) within 30 days prior to the index procedure or planned 3 months post-the index procedure.
• Hemodynamic instability or cardiogenic shock.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ling Tao

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Wang

CONTACT

86-18092798759; trialign@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Tricuspid valve repair

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 23, 2021
• Study Start: June 25, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share