Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group Ring
Patients in Group Ring will undergo tricuspid rigid ring annuloplasty
Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Group Band
Patients in Group Band will undergo flexible band annuloplasty
Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Interventions
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Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Eligibility Criteria
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Inclusion Criteria
* 2\. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
* 3\. Subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
* 4\. Subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography.
* 5\. Isolated functional symptomatic tricuspid regurgitation of moderate to severe or greater, with annular dilatation of ≥ 40mm;
* 6\. Requirement for concomitant left heart valve surgery;
* 7\. Requirement for concomitant coronary artery surgery;
* 8\. Requirement for concomitant atrial fibrillation surgery;
* 9\. Available and able to return to the study site for post-procedural follow-up examination;
Exclusion Criteria
* 2\. Subjects with mild tricuspid regurgitation;
* 3\. Emergency surgery;
* 4\. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
* 5\. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
* 6\. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
* 7\. Subjects with permanent or temporary pacemaker implantation;
* 8\. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
* 9\. History of mitral/tricuspid endocarditis within the last 12 months;
* 10\. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
* 11\. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
* 12\. Female patient is pregnant (urine HCG test result positive) or lactating;
* 13\. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
* 14\. Subjects with left ventricular ejection fraction (LVEF)≤20%.
18 Years
80 Years
ALL
No
Sponsors
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Nanjing Medical University
OTHER
Responsible Party
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Hong Liu
Staff of Department of Cardiothoracic Surgery
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Countries
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Central Contacts
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Facility Contacts
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Yong-feng Shao
Role: primary
References
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Veen KM, Etnel JRG, Quanjel TJM, Mokhles MM, Huygens SA, Rasheed M, Oei FBS, Ten Cate FJ, Bogers AJJC, Takkenberg JJM. Outcomes after surgery for functional tricuspid regurgitation: a systematic review and meta-analysis. Eur Heart J Qual Care Clin Outcomes. 2020 Jan 1;6(1):10-18. doi: 10.1093/ehjqcco/qcz032.
Other Identifiers
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JPH2019
Identifier Type: -
Identifier Source: org_study_id