N/A
N=40
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
Tricuspid Valve Insufficiency · Tricuspid Regurgitation · Tricuspid Valve Regurgitation · Cardiovascular Diseases · Heart Valve Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02981953 ↗Enrolled (actual)
40
Serious AEs
82.5%
Results posted
Jun 2021
Primary outcome: Primary: Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) — 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardioband Tricuspid (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) |
3; 1 | — |
| PRIMARY Access, Deployment and Positioning of the Cardioband Device |
39 | — |
| SECONDARY Technical Success |
— | — |
| SECONDARY Tricuspid Regurgitation [Paired Baseline and Follow-Up] |
0; 0; 0; 37; 0; 5 | — |
| SECONDARY Tricuspid Regurgitation [Full Analysis Data Set] |
0; 0; 0; 40; 0; 5 | — |
| SECONDARY Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] |
0.8; 0.6; 0.8; 0.4; 0.8; 0.4 | — |
| SECONDARY Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] |
0.8; 0.6; 0.4; 0.4; 0.3 | — |
| SECONDARY Regurgitant Volume [Paired Baseline and Follow-Up] |
97.1; 70.7; 104.2; 76.9; 76.5; 51.2 | — |
| SECONDARY Regurgitant Volume [Full Analysis Data Set] |
104.4; 86.7; 78.4; 79.4; 56.7 | — |
| SECONDARY TAPSE [Paired Baseline and Follow-Up] |
1.4; 1.3; 1.4; 1.4; 1.4; 1.3 | — |
| SECONDARY TAPSE [Full Analysis Data Set] |
1.5; 1.4; 1.4; 1.3; 1.4 | — |
| SECONDARY NYHA [Paired Baseline and Follow-Up] |
0; 6; 30; 1; 5; 22 | — |
| SECONDARY NYHA [Full Analysis Data Set] |
0; 6; 32; 2; 5; 22 | — |
| SECONDARY 6MWT [Paired Baseline and Follow-Up] |
232.0; 289.4; 236.1; 280.6; 222.2; 273.6 | — |
| SECONDARY 6MWT [Full Analysis Data Set] |
221.9; 289.4; 279.2; 273.6; 288.2 | — |
| SECONDARY Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] |
44.4; 56.7; 44.6; 63.6; 43.3; 59.6 | — |
| SECONDARY Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] |
43.8; 56.7; 63.6; 59.6; 58.0 | — |
| SECONDARY Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] |
56.7; 57.0; 56.2; 57.4; 56.6; 58.8 | — |
| SECONDARY Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] |
56.9; 57.0; 57.8; 59.0; 56.9 | — |
| SECONDARY Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set] |
— | — |
| SECONDARY Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set] |
— | — |
| SECONDARY NT-pro BNP [Full Analysis Data Set] |
2899.3; 2874.5; 2563.1; 2095.5; 2119.1 | — |
| SECONDARY Diuretic Therapy |
— | — |
| SECONDARY Bilirubin [Full Analysis Data Set] |
15.7; 14.0; 13.0; 11.6; 7.4 | — |
| SECONDARY Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] |
52.8; 52.1; 64.2; 49.5; 50.5 | — |
| SECONDARY Activity by Wearable Device |
— | — |
| SECONDARY Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] |
28.3; 31.9; 30.9; 32.3; 27.6 | — |
| SECONDARY Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] |
21.9; 25.1; 23.4; 24.6; 18.6 | — |
Summary
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.
Eligibility Criteria
Inclusion Criteria
- Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
- ≥18 years old
- New York Heart Association (NYHA) Class II-IVa
- Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
- LVEF ≥ 30%
- Patient is willing and able to comply with all specified study evaluations
- The Local Site Heart Team concur that surgery will not be offered as a treatment option
- Transfemoral access of the Cardioband is determined to be feasible
Exclusion Criteria
- Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
- Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
- Previous tricuspid valve repair or replacement
- Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
- Active endocarditis
- MI or known unstable angina within the 30 days prior to the index procedure
- Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
- Hemodynamic instability or on IV inotropes
- Cerebrovascular Accident (CVA) within the past 6 months
- Subject is on chronic dialysis
- Anemia (Hb < 9 g/dL) not corrected by transfusion
- Bleeding disorders or hypercoaguable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Contraindication to anticoagulants
- Known allergy to stainless steel, nickel, and/or polyester
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- Life expectancy of less than 12 months
- Impaired judgment and/or is undergoing emergency treatment
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- intra-cardiac masses, thrombi or vegetations
- Patients with cardiac cachexia
- Subjects in whom transesophageal echocardiography is contraindicated
- . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- Untreated clinically significant CAD requiring revascularization
- Echocardiographic evidence of severe right ventricular dysfunction
- Any coronary or endovascular surgery, within 3 months prior to procedure
Data sourced from ClinicalTrials.gov (NCT02981953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.