TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System (TRI-REPAIR)

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Cardiac Valve Annuloplasty
• Intervention / Treatment: Device: Cardioband Tricuspid

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 18 75877
    • Hopital Bichat-Claude Bernard
• Germany
  • Bonn, Germany
    • Bonn University - Universitätsklinikum Bonn
  • Hamburg, Germany, 5 20099
    • Asklepios Klinik, St. Georg
  • Hamburg, Germany
    • Universitätsklinik Hamburg Eppendorf, Herzzentrum
  • Köln, Germany
    • Universitätsklinikum Köln
  • Mainz, Germany
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Munich, Germany
    • LMU Klinikum der Universität München, Medizinische Klinik I
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardioband Tricuspid procedure; Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance	Device: Cardioband Tricuspid; The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)	Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)	30 days
Access, Deployment and Positioning of the Cardioband Device	Successful access, deployment and positioning of the Cardioband device	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Successful access, deployment and positioning of the Cardioband device and septolateral reduction.	1, 6, 12, and 24 months
Tricuspid Regurgitation [Paired Baseline and Follow-Up]	Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
Tricuspid Regurgitation [Full Analysis Data Set]	All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]	Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab	1, 6, 12, and 24 months over baseline
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]	All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
Regurgitant Volume [Paired Baseline and Follow-Up]	Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
Regurgitant Volume [Full Analysis Data Set]	All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
TAPSE [Paired Baseline and Follow-Up]	Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.	1, 6, 12, and 24 months over baseline
TAPSE [Full Analysis Data Set]	All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.	1, 6, 12, and 24 months over baseline
NYHA [Paired Baseline and Follow-Up]	NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest.	1, 6, 12, and 24 months over baseline
NYHA [Full Analysis Data Set]	All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest.	1, 6, 12, and 24 months over baseline
6MWT [Paired Baseline and Follow-Up]	Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
6MWT [Full Analysis Data Set]	Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]	The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.	1, 6, 12, and 24 months over baseline
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]	The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.	1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]	Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.	1, 6, 12, and 24 months over baseline
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]	All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.	1, 6, 12, and 24 months over baseline
Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]	Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]	Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
NT-pro BNP [Full Analysis Data Set]	N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Diuretic Therapy	Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Bilirubin [Full Analysis Data Set]	Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]	All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Activity by Wearable Device	Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]	All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.	1, 6, 12, and 24 months over baseline
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]	All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.	1, 6, 12, and 24 months over baseline

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Georg Nickenig, MD, University Hospital, Bonn

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): November 12, 2019

Study Registration Dates

• First Submitted: November 20, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Tricuspid; Valtech Cardio; Cardioband
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TR1-1

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