TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Cardiovascular Diseases Clinical Trial

— TRI-REPAIR  

Official title:

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981953
• Other study ID #: TR1-1
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 12, 2019

Study information

• Verified date: June 2021
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 12, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Access, Deployment and Positioning of the Cardioband Device	Successful access, deployment and positioning of the Cardioband device	Intra-procedure
Secondary	Technical Success	Successful access, deployment and positioning of the Cardioband device and septolateral reduction.	1, 6, 12, and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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