Clinical trial NCT02981953: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
Official title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Tricuspid Regurgitation
Tricuspid Valve Regurgitation
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Cardiac Valve Annuloplasty
Keywords: Valtech Cardio
Cardioband
Tricuspid
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.

Eligibility criteria: Inclusion Criteria:

1. Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
2. ≥18 years old
3. New York Heart Association (NYHA) Class II-IVa
4. Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
5. LVEF ≥ 30%
6. Patient is willing and able to comply with all specified study evaluations
7. The Local Site Heart Team concur that surgery will not be offered as a treatment option
8. Transfemoral access of the Cardioband is determined to be feasible

Exclusion Criteria:

1. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
2. Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
3. Previous tricuspid valve repair or replacement
4. Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
5. Active endocarditis
6. MI or known unstable angina within the 30 days prior to the index procedure
7. Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
8. Hemodynamic instability or on IV inotropes
9. Cerebrovascular Accident (CVA) within the past 6 months
10. Subject is on chronic dialysis
11. Anemia (Hb \< 9 g/dL) not corrected by transfusion
12. Bleeding disorders or hypercoaguable state
13. Active peptic ulcer or active gastrointestinal (GI) bleeding
14. Contraindication to anticoagulants
15. Known allergy to stainless steel, nickel, and/or polyester
16. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
17. 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
18. Life expectancy of less than 12 months
19. Impaired judgment and/or is undergoing emergency treatment
20. 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
21. intra-cardiac masses, thrombi or vegetations
22. Patients with cardiac cachexia
23. Subjects in whom transesophageal echocardiography is contraindicated
24. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
25. Untreated clinically significant CAD requiring revascularization
26. Echocardiographic evidence of severe right ventricular dysfunction
27. Any coronary or endovascular surgery, within 3 months prior to procedure

Primary outcomes:
measure: Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
timeFrame: 30 days
measure: Access, Deployment and Positioning of the Cardioband Device
timeFrame: Intra-procedure
Secondary outcomes:
measure: Technical Success
timeFrame: 1, 6, 12, and 24 months
measure: Tricuspid Regurgitation [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Tricuspid Regurgitation [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Regurgitant Volume [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Regurgitant Volume [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: TAPSE [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: TAPSE [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: NYHA [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: NYHA [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: 6MWT [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: 6MWT [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: NT-pro BNP [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Diuretic Therapy
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Bilirubin [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Activity by Wearable Device
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
measure: Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
timeFrame: 1, 6, 12, and 24 months over baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
city: Bonn
country: Germany
facility: Bonn University - Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik, St. Georg
city: Hamburg
country: Germany
facility: Universitätsklinik Hamburg Eppendorf, Herzzentrum
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Munich
country: Germany
facility: LMU Klinikum der Universität München, Medizinische Klinik I
city: Milano
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: University Hospital, Bonn
name: Georg Nickenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nickenig G, Weber M, Schuler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.
citation: Nickenig G, Weber M, Schueler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schafer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.