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

June 22, 2021 updated by: Xijing Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects has been informed the study and provided written informed consent.
  2. Age ≥ 18 and ≤ 85 years old.
  3. NYHA class II, III or ambulatory IV.
  4. The subject was diagnosed moderate to severe functional tricuspid regurgitation
  5. The subject was at high risk for open heart valve surgery. The heart team recommended tricuspid annuloplasty.

  6. 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.
  7. Sufficient posterior annular dimension for device implantation.

Exclusion Criteria:

  1. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg).
  2. History of heart transplant.
  3. Previous tricuspid valve repair or replacement (including artificial valve).
  4. Presence of a left ventricular assist device.
  5. Active endocarditis.
  6. Severe degenerative tricuspid valve disease.
  7. Severe aortic stenosis.
  8. The degree of mitral regurgitation is greater than grade 3.
  9. Complete occlusion due to chronic calcification of the right coronary artery.
  10. History of right internal jugular vein occlusion or thrombosis;
  11. 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).
  12. An indication of the presence of thrombi in the right ventricle or atrium.
  13. Myocardial infarction (MI) or known unstable angina within the 30 days prior to the index procedure.
  14. Any percutaneous coronary intervention (PCI) within 30 days prior to the index procedure or planned 3 months post-the index procedure.
  15. Hemodynamic instability or cardiogenic shock.
  16. Restrictive or hypertrophic cardiomyopathy. Constructive pericarditis, or other structural heart disease.
  17. Cerebrovascular accident (CVA) within the past 6 months
  18. 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.
  19. Anemia (hemoglobin <<90g/L) not corrected by transfusion. Thrombocytopenia (platelet count <100×109/L) or thrombocytosis (>750×109/L).
  20. Bleeding disorders or hypercoagulable state.
  21. Active peptic ulcer or active gastrointestinal bleeding.
  22. Contraindication to anticoagulant or antiplatelet therapies.
  23. Contraindications to or refusal of blood transfusions.
  24. Known allergy to stainless steel, nickel, platinum iridium, polyester and/or silk.
  25. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
  26. Life expectancy less than 12 months.
  27. Concurrent use of another clinical study product or use of another clinical study product within 30 days prior to enrolment.
  28. Other circumstances deemed unsuitable for inclusion by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Transcatheter tricuspid valve repair system (Trialign)
Subjects who received transcatheter tricuspid valve repair with Trialign will be included in this arm.
Device: Transcatheter tricuspid valve repair system (Trialign)
To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severe adverse device events (SADE)
Time Frame: 30 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 6 months
6 months
Technical success
Time Frame: 30 days

Technical success, defined as freedom from death with:

  1. Successful access, delivery and retrieval of the device delivery system;
  2. Deployment and correct positioning of the intended device(s) which is maintained and;
  3. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
30 days
Evaluation of tricuspid valve function
Time Frame: 6 months
6 months
New York Heart Association (NYHA) classification
Time Frame: 6 months
6 months
6-minute walk test (6MWT)
Time Frame: 6 months
6 months
EuroQol five dimensions questionnaire (EQ-5D)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Trialign study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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