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To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioband | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance [6MWT] | Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months. | Baseline, 6 and 12 months |
| Performance [MLHFQ] | Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce MR [Paired Baseline and Follow-Up] | Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1. | Post-adjustment, discharge, and 30 Days |
| Technical Feasibility of Cardioband Adjustment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Maisano, Prof. | Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bichat-Claude Bernard | Paris | 75877 | France | |||
| Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25326746 | Background | Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15. No abstract available. | |
| 26586779 |
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Of 62 patients originally enrolled, 1 excluded from full analysis data set (N=61) but included in safety analysis data set (N=62). Patient had severe MR, right heart failure (RHF), and tricuspid regurgitation (TR); determined to be a significant deviation from intended use of device. Study protocol amended to exclude severe RHF and TR.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single | Multi-center, prospective study with intra-subject comparisons |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single | Multi-center, prospective study with intra-subject comparisons |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days. | Posted | Count of Participants | Participants | 30 days |
|
|
1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
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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 | Single | Multi-center, prospective study with intra-subject comparisons |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 6 and 12 months |
| Performance [Intra-subject Comparison - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | Baseline, discharge, 6 and 12 months |
| Performance [Full Analysis Data Set - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | Baseline, discharge, 6 and 12 months |
The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire. |
| Immediately after procedure |
| Technical Success Rate of the Implantation of the Cardioband | The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System. | Immediately after implantation |
| Bonn |
| 53105 |
| Germany |
| Universitätskliniken zu Köln Klinik III Innere Medizin | Cologne | 50937 | Germany |
| Asklepios Klinik, St. Georg | Hamburg | 20099 | Germany |
| Zentrum für Kardiologie, Universitätsmedizin Mainz | Mainz | 55131 | Germany |
| Munich University Clinic | Munich | 81377 | Germany |
| Rambam Cardiology Research Unit | Haifa | 3109601 | Israel |
| Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" | Catania | 95123 | Italy |
| San Raffaele University Hospital | Milan | 20132 | Italy |
| St.Antonius Ziekenhuis | Nieuwegein | 3435 | Netherlands |
| UniversitätsSpital Zürich | Zurich | Switzerland |
| Background |
| Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18. |
| 30124798 | Derived | Messika-Zeitoun D, Nickenig G, Latib A, Kuck KH, Baldus S, Schueler R, La Canna G, Agricola E, Kreidel F, Huntgeburth M, Zuber M, Verta P, Grayburn P, Vahanian A, Maisano F. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-472. doi: 10.1093/eurheartj/ehy424. |
| 27712741 | Derived | Nickenig G, Hammerstingl C, Schueler R, Topilsky Y, Grayburn PA, Vahanian A, Messika-Zeitoun D, Urena Alcazar M, Baldus S, Volker R, Huntgeburth M, Alfieri O, Latib A, La Canna G, Agricola E, Colombo A, Kuck KH, Kreidel F, Frerker C, Tanner FC, Ben-Yehuda O, Maisano F. Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005. |
| Study exit due to secondary intervention |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| EuroSCORE II | 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:
| Mean | Standard Deviation | Score |
|
| New York Heart Association (NYHA) Functional Class III or IV | NYHA Classification - The stages of heart failure:
| Count of Participants | Participants |
|
| Ischemic Etiology of Regurgitation | Count of Participants | Participants |
|
| Left Ventricule Ejection Fraction (LVEF) | Mean | Standard Deviation | Percent Fraction |
|
| Previous Coronary Artery Bypass Graft (CABG) | Data Unavailable for 2 patients. | Count of Participants | Participants |
|
| Renal Insufficiency | Count of Participants | Participants |
|
| Atrial Fibrillation | Data unavailable for 1 patient. | Count of Participants | Participants |
|
|
| Secondary | Performance [6MWT] | Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months. | Intra-subject comparison of 18 patients who had data at all three time points (baseline, 6 and 12 months). | Posted | Mean | Standard Deviation | Meters | Baseline, 6 and 12 months |
|
|
|
| Secondary | Performance [MLHFQ] | Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life. | Intra-subject comparison of 27 patients who had data at all three time points (baseline, 6 and 12 months). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 and 12 months |
|
|
|
| Secondary | Performance [Intra-subject Comparison - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | Intra-subject comparison of 26 patients who were assessed for MR grade across all four time points (baseline, discharge, 6 and 12 months). | Posted | Count of Participants | Participants | Baseline, discharge, 6 and 12 months |
|
|
|
| Secondary | Performance [Full Analysis Data Set - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | The outcome is reported where data is available. | Posted | Count of Participants | Participants | Baseline, discharge, 6 and 12 months |
|
|
|
| Other Pre-specified | Reduce MR [Paired Baseline and Follow-Up] | Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1. | The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and post-adjustment, discharge, and 30 days is 47, 50 and 46, respectively. | Posted | Count of Participants | Participants | Post-adjustment, discharge, and 30 Days |
|
|
|
| Other Pre-specified | Technical Feasibility of Cardioband Adjustment | The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire. | Posted | Count of Participants | Participants | Immediately after procedure |
|
|
|
| Other Pre-specified | Technical Success Rate of the Implantation of the Cardioband | The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System. | Posted | Count of Participants | Participants | Immediately after implantation |
|
|
|
| 44 |
| 62 |
| 21 |
| 62 |
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Atrial Septal Defect | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Bundle Branch Block Left | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Dyspnoea | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Left Ventricular Failure | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Mitral Valve Disease | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment | CEC Adjudicated |
|
| Cataract | Eye disorders | Systematic Assessment | CEC Adjudicated |
|
| Melaena | Gastrointestinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Chest Pain | General disorders | Systematic Assessment | CEC Adjudicated |
|
| Device Dislocation | General disorders | Systematic Assessment | CEC Adjudicated |
|
| Multi-Organ Failure | General disorders | Systematic Assessment | CEC Adjudicated |
|
| Oedema due to Cardiac Disease | General disorders | Systematic Assessment | CEC Adjudicated |
|
| Systemic Inflammatory Response Syndrome | General disorders | Systematic Assessment | CEC Adjudicated |
|
| Pneumonia | Infections and infestations | Systematic Assessment | CEC Adjudicated |
|
| Sepsis | Infections and infestations | Systematic Assessment | CEC Adjudicated |
|
| Septic Shock | Infections and infestations | Systematic Assessment | CEC Adjudicated |
|
| Staphylococcal Infection | Infections and infestations | Systematic Assessment | CEC Adjudicated |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | CEC Adjudicated |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment | CEC Adjudicated |
|
| Iatrogenic Injury | Injury, poisoning and procedural complications | Systematic Assessment | CEC Adjudicated |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment | CEC Adjudicated |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment | CEC Adjudicated |
|
| Blood Glucose Increased | Investigations | Systematic Assessment | CEC Adjudicated |
|
| Haemoglobin Decreased | Investigations | Systematic Assessment | CEC Adjudicated |
|
| Troponin Increased | Investigations | Systematic Assessment | CEC Adjudicated |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | CEC Adjudicated |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment | CEC Adjudicated |
|
| Meniscus Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | CEC Adjudicated |
|
| Carcinoma in situ of Eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | CEC Adjudicated |
|
| Large Intestine Polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | CEC Adjudicated |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | CEC Adjudicated |
|
| Haemorrhagic Stroke | Nervous system disorders | Systematic Assessment | CEC Adjudicated |
|
| Hemiparesis | Nervous system disorders | Systematic Assessment | CEC Adjudicated |
|
| Ischaemic Stroke | Nervous system disorders | Systematic Assessment | CEC Adjudicated |
|
| Syncope | Nervous system disorders | Systematic Assessment | CEC Adjudicated |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment | CEC Adjudicated |
|
| Actinomycotic Pulmonary Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CEC Adjudicated |
|
| Cardiac Pacemaker Replacement | Surgical and medical procedures | Systematic Assessment | CEC Adjudicated |
|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment | CEC Adjudicated |
|
| Implantable Defibrillator Insertion | Surgical and medical procedures | Systematic Assessment | CEC Adjudicated |
|
| Air Embolism | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Device Fastener Issue | General disorders | Systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
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|
| Title | Measurements |
|---|---|
|
| Discharge |
|
| 6 Months |
|
| 1 Year |
|
| Trace - Mild (0-1+) |
|
| Discharge |
|
|
| 6 Months |
|
|
| 1 Year |
|
|
|
| 30 Days |
|
|