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

Primary Purpose

Tricuspid Regurgitation

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcatheter tricuspid valve repair system (Trialign)

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
1. Systolic pulmonary artery pressure (SPAP) ≤ 60mmHg.
2. Left ventricular ejection fraction (LVEF) ≥ 30%.
3. Right ventricle tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm.
4. Tricuspid valve annular diameter ≤ 55 mm.
5. Tricuspid EROA ≤ 1.75 cm2.
6. Functional tricuspid valve regurgitation pathology with a structurally normal valve.
Sufficient posterior annular dimension for device implantation.

Exclusion Criteria:

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.
Restrictive or hypertrophic cardiomyopathy. Constructive pericarditis, or other structural heart disease.
Cerebrovascular accident (CVA) within the past 6 months
Serum creatinine > 2.5 mg/dL (or 221 μmol/L), Impaired kidney function, defined as glomerular filtration rate (GFR) of 30 mL/min or less.
Anemia (hemoglobin <<90g/L) not corrected by transfusion. Thrombocytopenia (platelet count <100×109/L) or thrombocytosis (>750×109/L).
Bleeding disorders or hypercoagulable state.
Active peptic ulcer or active gastrointestinal bleeding.
Contraindication to anticoagulant or antiplatelet therapies.
Contraindications to or refusal of blood transfusions.
Known allergy to stainless steel, nickel, platinum iridium, polyester and/or silk.
Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
Life expectancy less than 12 months.
Concurrent use of another clinical study product or use of another clinical study product within 30 days prior to enrolment.
Other circumstances deemed unsuitable for inclusion by the researcher.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter tricuspid valve repair system (Trialign)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical success

Technical success, defined as freedom from death with: Successful access, delivery and retrieval of the device delivery system; Deployment and correct positioning of the intended device(s) which is maintained and; No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.

Evaluation of tricuspid valve function

New York Heart Association (NYHA) classification

6-minute walk test (6MWT)

EuroQol five dimensions questionnaire (EQ-5D)

Incidence of adverse events

Full Information

NCT ID

NCT04936802

First Posted

June 3, 2021

Last Updated

June 22, 2021

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04936802

Brief Title

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

Official Title

Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 25, 2021 (Anticipated)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tricuspid Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Tricuspid valve repair

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transcatheter tricuspid valve repair system (Trialign)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcatheter tricuspid valve repair system (Trialign)

Intervention Description

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

Primary Outcome Measure Information:

Title

Severe adverse device events (SADE)

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Technical success

Description

Time Frame

30 days

Title

Evaluation of tricuspid valve function

Time Frame

6 months

Title

New York Heart Association (NYHA) classification

Time Frame

6 months

Title

6-minute walk test (6MWT)

Time Frame

6 months

Title

EuroQol five dimensions questionnaire (EQ-5D)

Time Frame

6 months

Title

Incidence of adverse events

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Restrictive or hypertrophic cardiomyopathy. Constructive pericarditis, or other structural heart disease. Cerebrovascular accident (CVA) within the past 6 months Serum creatinine > 2.5 mg/dL (or 221 μmol/L), Impaired kidney function, defined as glomerular filtration rate (GFR) of 30 mL/min or less. Anemia (hemoglobin <<90g/L) not corrected by transfusion. Thrombocytopenia (platelet count <100×109/L) or thrombocytosis (>750×109/L). Bleeding disorders or hypercoagulable state. Active peptic ulcer or active gastrointestinal bleeding. Contraindication to anticoagulant or antiplatelet therapies. Contraindications to or refusal of blood transfusions. Known allergy to stainless steel, nickel, platinum iridium, polyester and/or silk. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure. Life expectancy less than 12 months. Concurrent use of another clinical study product or use of another clinical study product within 30 days prior to enrolment. Other circumstances deemed unsuitable for inclusion by the researcher.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Wang

Phone

86-18092798759

trialign@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ling Tao

Organizational Affiliation

Xijing Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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