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Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.
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The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.
Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioband procedure | Other | Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioband | Device | Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. | Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distance Walked on 6 Minute Walk Test | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline | 6 months over Baseline |
| Change in Mitral Regurgitation Severity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distance Walked on 6 Minute Walk Test | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline | 12, and 24 months over baseline |
| Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat hospital | Paris | 18 75877 | France | |||
| Bad Nauheim, Kerckhoff-Klinik |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardioband | Patients who were enrolled and had the Cardioband procedure attempted |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2017 |
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Mitral Regurgitation at 6, 12, and 24 months compared to baseline
| 6, 12, and 24 months over baseline |
Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. |
| 6, 12, and 24 months over baseline |
| Change in New York Heart Association (NYHA) Class | NYHA Class at 6, 12, and 24 months compared to baseline | 6, 12, and 24 months over baseline |
| Change in Left Ventricular End Diastolic Volume (LVEDV) | Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline | 6, 12, and 24 months over baseline |
| Change in Left Ventricular End Systolic Volume (LVESV) | Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline | 6, 12, and 24 months over baselines |
| Number of Participants With Device Success | Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge. | Discharge |
| Number of Participants With Patient Success | Individual patient success (measured at 6 months and 1 year) defined as device success and the following:
| 6 and 12 months |
| Number of Days Alive and Out of Hospital | Days alive and out of hospital due to major cardiovascular events at 1 year | 12 months |
| Freedom From All-cause Mortality and Major Adverse Events (AE) | Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later. | 30 days from implant procedure or hospital discharge, whichever is later. |
| Need for Urgent/Emergent Surgical Intervention | Number of patients who undergo urgent/emergent surgical intervention post procedure | 24 months |
| Bad Nauheim |
| 61231 |
| Germany |
| Bonn University | Bonn | Germany |
| Koln, Universitätsklinikum | Cologne | Germany |
| Universitätsklinikum Gießen und Marburg | Giessen | Germany |
| University Hospital Halle (Saale) | Halle | Germany |
| Asklepios Klinik, St. Georg | Hamburg | 5 20099 | Germany |
| Universitäres Herzzentrum Hamburg GmbH | Hamburg | Germany |
| Universitatsmedizin Mainz | Mainz | Germany |
| Hospital san raffaele | Milan | 20132 | Italy |
| Implanted |
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| 30 Day Follow-Up Completed |
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| COMPLETED | Completed Study (2 years) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardioband | Patients who were enrolled and had the Cardioband procedure attempted |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| EuroScore II | The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a risk model which allows the calculation of the risk of death after a heart operation. EuroScore II risk levels are as follows: Low risk: <8 Moderate risk: 8-10 High risk: >10 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| NYHA Functional Class III or IV | 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. | Count of Participants | Participants |
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| Ischemic Etiology of Regurgitation | Count of Participants | Participants |
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| Dilated Cardiomyopathy | Count of Participants | Participants |
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| Previous Coronary Artery Bypass Graft | Count of Participants | Participants |
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| Chronic Renal Disease | Count of Participants | Participants |
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| Paroxysmal, Persistent, Chronic Atrial Flutter/Fibrillation | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. | Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline | Intra-subject comparison of patients with paired data at baseline and 30 days | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Change in Distance Walked on 6 Minute Walk Test | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline | Intra-subject comparison of patients with paired data at baseline and 6 months | Posted | Median | Standard Deviation | Meters | 6 months over Baseline |
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| Secondary | Change in Mitral Regurgitation Severity | Mitral Regurgitation at 6, 12, and 24 months compared to baseline | This planned endpoint of change mitral regurgitation severity in was unable to be analyzed due to the small sample size that was achieved in this study. Data available at each time point were reported as number of patients with MR grades None/Trace, Mild, Moderate, Severe. | Posted | Count of Participants | Participants | 6, 12, and 24 months over baseline |
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| Other Pre-specified | Change in Distance Walked on 6 Minute Walk Test | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 12, and 24 months over baseline |
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| Other Pre-specified | Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 6, 12, and 24 months over baseline |
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| Other Pre-specified | Change in New York Heart Association (NYHA) Class | NYHA Class at 6, 12, and 24 months compared to baseline | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 6, 12, and 24 months over baseline |
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| Other Pre-specified | Change in Left Ventricular End Diastolic Volume (LVEDV) | Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 6, 12, and 24 months over baseline |
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| Other Pre-specified | Change in Left Ventricular End Systolic Volume (LVESV) | Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 6, 12, and 24 months over baselines |
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| Other Pre-specified | Number of Participants With Device Success | Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge. | The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis. | Posted | Count of Participants | Participants | Discharge |
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| Other Pre-specified | Number of Participants With Patient Success | Individual patient success (measured at 6 months and 1 year) defined as device success and the following:
| The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis. | Posted | Count of Participants | Participants | 6 and 12 months |
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| Other Pre-specified | Number of Days Alive and Out of Hospital | Days alive and out of hospital due to major cardiovascular events at 1 year | This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study | Posted | 12 months |
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| Other Pre-specified | Freedom From All-cause Mortality and Major Adverse Events (AE) | Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later. | Posted | Count of Participants | Participants | 30 days from implant procedure or hospital discharge, whichever is later. |
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| Other Pre-specified | Need for Urgent/Emergent Surgical Intervention | Number of patients who undergo urgent/emergent surgical intervention post procedure | Posted | Count of Participants | Participants | 24 months |
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2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardioband | Patients who were enrolled and had the Cardioband procedure attempted | 5 | 11 | 9 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | One patient experienced two Atrial Fibrillation adverse events (one serious and one non-serious). Both episodes are reported for this patient, one under Serious Adverse Events and the other under Other (Not Including Serious) Adverse Events. |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | Systematic Assessment |
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| Large Intestine Polyp | Gastrointestinal disorders | Systematic Assessment |
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| Mechanical Ileus | Gastrointestinal disorders | Systematic Assessment |
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| General Physical Health Deterioration | General disorders | Systematic Assessment |
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| Bacterial Infection | Infections and infestations | Systematic Assessment |
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| Dermohypodermitis | Infections and infestations | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| IIIrd Nerve Disorder | Nervous system disorders | Systematic Assessment |
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| Device Malfunction | Product Issues | Systematic Assessment |
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| Completed Suicide | Psychiatric disorders | Systematic Assessment |
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| Haemorrhage Urinary Tract | Renal and urinary disorders | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Cervix Oedema | Reproductive system and breast disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Circulatory Collapse | Vascular disorders | Systematic Assessment |
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| Embolism | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Metabolic Disorder | Metabolism and nutrition disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Heparin Induced Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Iron Deficiency Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | One patient experienced two Atrial Fibrillation adverse events (one serious and one non-serious). Both episodes are reported for this patient, one under Serious Adverse Events and the other under Other (Not Including Serious) Adverse Events. |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Creactive Protein Increased | Investigations | Systematic Assessment |
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| Haemoglobin Decreased | Investigations | Systematic Assessment |
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| Weight Increased | Investigations | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Puncture Site Infection | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Tooth Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Depressed Level of Conciousness | Nervous system disorders | Systematic Assessment |
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| Device Pacing Issue | Product Issues | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypochromic Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
| Aug 7, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
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| Title | Denominators | Categories | ||||
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| Severe |
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| Severe |
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