Tricuspid RegurgitationNCT04936802
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
A study testing Transcatheter tricuspid valve repair system (Trialign) in people with Tricuspid Regurgitation, run by Xijing Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Transcatheter tricuspid valve repair system (Trialign)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Transcatheter tricuspid valve repair system (Trialign)
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter tricuspid valve repair system (Trialign)Device
To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter tricuspid valve repair system (Trialign) | Experimental | Subjects who received transcatheter tricuspid valve repair with Trialign will be included in this arm. Receives: Device: Transcatheter tricuspid valve repair system (Trialign) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
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.
Measured: 30 days
Evaluation of tricuspid valve function
Measured: 6 months
New York Heart Association (NYHA) classification
Measured: 6 months
6-minute walk test (6MWT)
Measured: 6 months
EuroQol five dimensions questionnaire (EQ-5D)
Measured: 6 months
Incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start25 Jun 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tricuspid valve repair
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Tao, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936802
- Sponsor's protocol ID
- Trialign study
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04936802
- Acronym / sponsor ID
- Trialign study
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 25 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tricuspid valve repair
| Arm | Type | Receives |
|---|---|---|
| Transcatheter tricuspid valve repair system (Trialign) | Experimental | Device: Transcatheter tricuspid valve repair system (Trialign)Subjects who received transcatheter tricuspid valve repair with Trialign will be included in this arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter tricuspid valve repair system (Trialign)To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation | Device | Transcatheter tricuspid valve repair system (Trialign) |
Primary outcome
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.
6 secondary outcomes
Technical success
Time frame: 30 days
Evaluation of tricuspid valve function
Time frame: 6 months
New York Heart Association (NYHA) classification
Time frame: 6 months
6-minute walk test (6MWT)
Time frame: 6 months
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: 6 months
Incidence of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Tao principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter tricuspid valve repair system (Trialign) in people with Tricuspid Regurgitation, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Wang (86-18092798759, trialign@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse device events (SADE) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.