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

Primary Purpose

Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Cardioband Tricuspid

About this trial

This is an interventional treatment trial for Tricuspid Valve Insufficiency focused on measuring Valtech Cardio, Cardioband, Tricuspid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Bichat-Claude Bernard
Bonn University - Universitätsklinikum Bonn
Asklepios Klinik, St. Georg
Universitätsklinik Hamburg Eppendorf, Herzzentrum
Universitätsklinikum Köln
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
LMU Klinikum der Universität München, Medizinische Klinik I
Ospedale San Raffaele

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardioband Tricuspid procedure

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Access, Deployment and Positioning of the Cardioband Device

Successful access, deployment and positioning of the Cardioband device

Secondary Outcome Measures

Technical Success

Successful access, deployment and positioning of the Cardioband device and septolateral reduction.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]

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.

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.

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.

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.

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.

Diuretic Therapy

Diuretic Therapy data available at 1 month, 6 months, 12 months, 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.

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.

Activity by Wearable Device

Activity by wearable device available data at 1 month, 6 months, 12 months, 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.

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.

Full Information

NCT ID

NCT02981953

First Posted

November 20, 2016

Last Updated

June 4, 2021

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT02981953

Brief Title

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Acronym

TRI-REPAIR

Official Title

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases, Heart Valve Diseases, Heart Diseases, Cardiac Valve Annuloplasty

Keywords

Valtech Cardio, Cardioband, Tricuspid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardioband Tricuspid procedure

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Cardioband Tricuspid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)

Description

Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)

Time Frame

30 days

Title

Access, Deployment and Positioning of the Cardioband Device

Description

Successful access, deployment and positioning of the Cardioband device

Time Frame

Intra-procedure

Secondary Outcome Measure Information:

Title

Technical Success

Description

Successful access, deployment and positioning of the Cardioband device and septolateral reduction.

Time Frame

1, 6, 12, and 24 months

Title

Tricuspid Regurgitation [Paired Baseline and Follow-Up]

Description

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.

Time Frame