Cardiovascular Diseases Clinical Trial
— TRI-REPAIROfficial title:
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
NCT number | NCT02981953 |
Other study ID # | TR1-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | November 12, 2019 |
Verified date | June 2021 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
France, Germany, Italy,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|