TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Not Applicable

Completed

Conditions: Tricuspid Regurgitation
Heart Valve Diseases
Heart Diseases
Tricuspid Valve Insufficiency
Tricuspid Valve Regurgitation
Cardiac Valve Annuloplasty
Cardiovascular Diseases

Interventions: Device: Cardioband Tricuspid

Registration Number: NCT02981953

Lead Sponsor: Edwards Lifesciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardioband Tricuspid procedure	Cardioband Tricuspid	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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.
Regurgitant Volume [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
TAPSE [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
NYHA [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Technical Success	1, 6, 12, and 24 months	Successful access, deployment and positioning of the Cardioband device and septolateral reduction.
Tricuspid Regurgitation [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	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.
6MWT [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Bilirubin [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Tricuspid Regurgitation [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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.
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab
Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.
Regurgitant Volume [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
TAPSE [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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.
6MWT [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	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.
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]	1, 6, 12, and 24 months over baseline	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.
Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.
NYHA [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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.
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	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.
NT-pro BNP [Full Analysis Data Set]	1, 6, 12, and 24 months over baseline	N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Diuretic Therapy	1, 6, 12, and 24 months over baseline	Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Activity by Wearable Device	1, 6, 12, and 24 months over baseline	Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.

Trial Locations

Locations (8): Hôpital Bichat-Claude Bernard
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Paris, France
Bonn University - Universitätsklinikum Bonn
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Bonn, Germany
Universitätsklinikum Köln
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Köln, Germany
Ospedale San Raffaele
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Milano, Italy
LMU Klinikum der Universität München, Medizinische Klinik I
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Munich, Germany
Asklepios Klinik, St. Georg
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Hamburg, Germany
Universitätsklinik Hamburg Eppendorf, Herzzentrum
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Hamburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Mainz, Germany