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The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.
A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.
Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral valve replacement | Device | Transcatheter mitral valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From All-cause Mortality and Major Adverse Events | Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention | From the time of implant procedure to 30 days or hospital discharge (whichever is later) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention | 30 days, 90 days, 180 days and annually to five years | |
| Individual 30 Day Rates of Device and Procedure Related Major Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anson Cheung, MD | University of British Columbia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24944303 | Background | De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available. | |
| 24939033 |
| Label | URL |
|---|---|
| Company website with product information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system Mitral valve replacement: Transcatheter mitral valve replacement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system Mitral valve replacement: Transcatheter mitral valve replacement |
| 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 | Freedom From All-cause Mortality and Major Adverse Events | Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention | Analysis population is all participants implanted with the Tiara valve. | Posted | Count of Participants | Participants | From the time of implant procedure to 30 days or hospital discharge (whichever is later) |
|
|
30 days
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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 | Treatment | Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system Mitral valve replacement: Transcatheter mitral valve replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Read, Clinical Study Manager | Neovasc | 8558025180 | 323 | lread@neovasc.com |
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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 | Nov 17, 2015 | Mar 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015154 | Esophageal Motility Disorders |
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|
| 30 days |
| Number and Percentage of Subjects With Progression of Heart Failure | Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation | One year |
| Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter | Mitral regurgitation < moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient < 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures | Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years |
| Performance | Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures | 30 days, 90 days, 180 days and annually for five years |
| Days Alive and Out of Hospital | Number of days alive and not hospitalized | At one year |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48188 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ZNA Middelheim | Antwerp | B 2060 | Belgium |
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available. |
| 23084102 | Background | Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA Functional Class | Class I:Patients with cardiac disease but without resulting limitations of physical activity.Class II:Patients with cardiac disease resulting in slight limitation of physical activity and are comfortable at rest.Class III:Patients with cardiac disease resulting in marked limitation of physical activity and are comfortable at rest.Class IV:Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased. | Number | participants |
|
| Predicted Surgical Mortality | The Society of Thoracic Surgeons' risk models predict the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. The models are primarily used to adjust for case mix when comparing outcomes across institutions with different patient populations. Such comparisons are provided in the Database reports received by STS Database participants. The STS models are also used by physicians and patients as tools for understanding the possible risks of surgery. | Mean | Standard Deviation | Probability Percentage |
|
| Ejection Fraction | Mean | Standard Deviation | Percentage |
|
| Mitral Regurgitation Severity | Measurement assessed by independent echocardiographic core laboratory utilizing quantitative and qualitative assessments. Mitral Regurgitation is graded by None, Trace, Mild, Moderate, Moderate-Severe and Severe. | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Chronic Lung Disease | Count of Participants | Participants |
|
| Peripheral Vascular Disease | Count of Participants | Participants |
|
| Renal Dysfunction | Data was not collected on 4 treated subjects. | Count of Participants | Participants |
|
| Obstructive Coronary Artery Disease | Data was not collected on 4 treated subjects | Count of Participants | Participants |
|
| Previous Coronary Artery Bypass | Count of Participants | Participants |
|
| Previous Percutaneous Coronary Intervention | Data was not collected on 4 treated subjects. | Count of Participants | Participants |
|
| Previous Valve Replacement or Repair | Count of Participants | Participants |
|
| Heart Failure | Count of Participants | Participants |
|
| Previous Myocardial Infarction | Count of Participants | Participants |
|
| Cardiomyopathy | Count of Participants | Participants |
|
| Previous Clinically Significant Arrhythmia | Count of Participants | Participants |
|
| Prior Pacemaker/ICD/CRT | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention | Not Posted | 30 days, 90 days, 180 days and annually to five years | Participants |
| Secondary | Individual 30 Day Rates of Device and Procedure Related Major Adverse Events |
| Not Posted | 30 days | Participants |
| Secondary | Number and Percentage of Subjects With Progression of Heart Failure | Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation | Not Posted | One year | Participants |
| Secondary | Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter | Mitral regurgitation < moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient < 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures | Not Posted | Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years | Participants |
| Secondary | Performance | Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures | Not Posted | 30 days, 90 days, 180 days and annually for five years | Participants |
| Secondary | Days Alive and Out of Hospital | Number of days alive and not hospitalized | Not Posted | At one year | Participants |
| 3 |
| 27 |
| 19 |
| 27 |
| 6 |
| 27 |
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Stroke/TIA | Nervous system disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Vascular Access Site and Access Related Complications | Vascular disorders | Systematic Assessment |
|
| Arrhythmia and Conduction System Disturbances | Cardiac disorders | Systematic Assessment |
|
| Progression of Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Decreased Ejection Fraction | Cardiac disorders | Systematic Assessment |
|
| Infection - Not related to Study Device/Procedure | Infections and infestations | Systematic Assessment |
|
| Mitral Regurgitation | Cardiac disorders | Systematic Assessment |
|
| Multi System Organ Failure | General disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Valve Migration | Cardiac disorders | Systematic Assessment |
|
| Eye Infection | Eye disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | No symptoms reported. Troponin increase and ECG changes noted meeting protocol definition. Adjudicated by the CEC as non serious |
|
| Pre Syncope | Nervous system disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adjudicated by the CEC as non serious |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adjudicated by the CEC as non serious |
|
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| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |