Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EW Tricuspid Transcatheter Repair System | Experimental | Edwards (EW) Tricuspid Transcatheter Repair System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EW Tricuspid Transcatheter Repair System | Device | Treatment with the EW Tricuspid Transcatheter Repair System |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only. | At 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Alive, with
| Implant Procedure |
| Device Success |
Not provided
Inclusion Criteria:
Exclusion Criteria
Tricuspid valve/right heart anatomy not suitable for the study device:
Moderate or greater tricuspid valve stenosis
Untreated clinically significant coronary artery disease requiring immediate revascularization
Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure
Myocardial infarction within 30 days of scheduled implant procedure
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure
Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
Active endocarditis or infection within 3 months of scheduled implant procedure
Cerebrovascular accident within 3 months of scheduled implant procedure
Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
Evidence of right sided intracardiac mass, thrombus, or vegetation
Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
Known hypersensitivity to cobalt chromium, nitinol or titanium
Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
Patient is a current intravenous drug user
Female of child-bearing potential is pregnant or lactating
Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
Patient requires emergent/emergency treatment for tricuspid insufficiency
Patient is under guardianship
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital, Providence Health Care Research Institute | Vancouver | British Columbia | V6E 1M7 | Canada | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EW Tricuspid Transcatheter Repair System | Edwards (EW) Tricuspid Transcatheter Repair System EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Revision A.G.3 | Oct 10, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Alive, with
|
| At 1 month, 6 months, 1, 2, and 3 years |
| Procedural Success | Device Success, and None of the following device or procedure related Serious Adverse Events (SAE):
| At 1 month |
| Clinical Outcomes [Heart Failure Re-Hospitalization Rates] | Re-hospitalization rates for the underlying condition (heart failure) | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates] | Re-intervention rates for the underlying condition (tricuspid regurgitation) | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Changes in Peripheral Edema] | Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Change in New York Heart Association (NYHA) Class] | Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: 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. | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Change in 6 Minute Walk Test Distance] | Change in 6 minute walk test distance (meters) compared to baseline | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire] | Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning. | At 1 month, 6 months, 1, 2 and 3 years |
| Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)] | Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. 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. | At 1 month, 6 months, 1, 2 and 3 years |
| Toronto General Hospital |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval | Québec | G1V 4G5 | Canada |
| Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| Hōpital Charles Nicolle | Rouen | 76031 | France |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Charite-Universitätsmedzin Berlin | Berlin | 10117 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Munich University Clinic, Ludwig-Maximilian University | Munich | 81377 | Germany |
| Hygeia Hospital | Athens | 15123 | Greece |
| Inselspital, Universitätsspital Bern | Bern | 3010 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EW Tricuspid Transcatheter Repair System | Edwards (EW) Tricuspid Transcatheter Repair System EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| New York Heart Association Class (NYHA) | 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. | Count of Participants | Participants |
| |||||||||||||||||
| The European System for Cardiac Operative Risk Evaluation: EuroScore II | Measure Description: 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. The higher the score percentage, the higher the risk of an adverse outcome. The EuroScore II Scale ranges from 0-100%. Although the maximum value of the full range is 100%, any percentage over 10 is considered a high risk for surgical mortality. EuroScore II risk levels are as follows: < 8%: Low risk 8-10%: Moderate risk >10%: High risk | Mean | Standard Deviation | Percentage of surgical risk |
| ||||||||||||||||
| History of Heart Failure | Count of Participants | Participants |
| ||||||||||||||||||
| Hospitalization for Heart Failure prior 6 months | Count of Participants | Participants |
| ||||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||||
| Cancer | Count of Participants | Participants |
| ||||||||||||||||||
| Carotid Artery Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Coagulopathy | Count of Participants | Participants |
| ||||||||||||||||||
| Coronary Artery Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Hyperlipidemia | Count of Participants | Participants |
| ||||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Liver Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Myocardial Infarction (MI) | Count of Participants | Participants |
| ||||||||||||||||||
| Pacemaker/Implantable cardioverter-defibrillator (ICD) | Count of Participants | Participants |
| ||||||||||||||||||
| Peripheral Vascular Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Percutaneous Coronary Intervention (PCI) | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Coronary Artery Bypass Graft (CABG) | Count of Participants | Participants |
| ||||||||||||||||||
| Prior valve implant | Count of Participants | Participants |
| ||||||||||||||||||
| Pulmonary Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Pulmonary Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Stroke | Count of Participants | Participants |
| ||||||||||||||||||
| Transient Ischemic Attack (TIA) | Count of Participants | Participants |
|
| 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 | All-cause Mortality | The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only. | As Treated (AT) Cohort: All subjects who are enrolled and undergo the study procedure (chest incision) | Posted | Count of Participants | Participants | At 30 days. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Technical Success | Alive, with
| As Treated (AT) Cohort: all subjects who are enrolled and undergo the study procedure (chest incision) | Posted | Count of Participants | Participants | Implant Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Device Success | Alive, with
| Implanted Cohort: all subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room *Count of Participants reflects those subjects who had been implanted, and who had all components of device success | Posted | Count of Participants | Participants | At 1 month, 6 months, 1, 2, and 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Procedural Success | Device Success, and None of the following device or procedure related Serious Adverse Events (SAE):
| Implanted Cohort: all subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room Denominator reflects those patients who experienced device success and no device or procedure related SAEs | Posted | Count of Participants | Participants | At 1 month |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Heart Failure Re-Hospitalization Rates] | Re-hospitalization rates for the underlying condition (heart failure) | Kaplan Meier Analysis on Subjects Experiencing Heart Failure Rehospitalization Events | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month, 6 months, 1, 2 and 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates] | Re-intervention rates for the underlying condition (tricuspid regurgitation) | Kaplan Meier Analysis on Subjects Experiencing Re-intervention for Tricuspid Reintervention | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month, 6 months, 1, 2 and 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Changes in Peripheral Edema] | Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline | Implanted Cohort: All subjects who underwent the study procedure (chest incision), received and retained the investigational device upon leaving the procedure room *Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up | Posted | Mean | Standard Deviation | kg | At 1 month, 6 months, 1, 2 and 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Change in New York Heart Association (NYHA) Class] | Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: 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. | Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room *Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up | Posted | Count of Participants | Participants | At 1 month, 6 months, 1, 2 and 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Change in 6 Minute Walk Test Distance] | Change in 6 minute walk test distance (meters) compared to baseline | Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room *Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up | Posted | Mean | Standard Deviation | Meters | At 1 month, 6 months, 1, 2 and 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire] | Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning. | Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room *Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up | Posted | Mean | Standard Deviation | score on a scale | At 1 month, 6 months, 1, 2 and 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)] | Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. 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. | Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room *Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up | Posted | Mean | Standard Deviation | score on a scale | At 1 month, 6 months, 1, 2 and 3 years |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EW Tricuspid Transcatheter Repair System | Edwards (EW) Tricuspid Transcatheter Repair System EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System As Treated (AT) Cohort: all subjects who are enrolled and undergo the study procedure (chest incision) | 16 | 25 | 20 | 25 | 23 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac cirrhosis | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Intervertebral discitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Heart injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lower limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ventricle rupture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Anaemia | Vascular disorders | Systematic Assessment |
| ||
| Epistaxis | Vascular disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Intra-abdominal haematoma | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery haematoma | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Syncope | Vascular disorders | Systematic Assessment |
| ||
| Vena cava thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrogenic anaemia | Renal and urinary disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Intestinal ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Amyloidosis | Immune system disorders | Systematic Assessment |
| ||
| Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Device physical property issue | Product Issues | Systematic Assessment |
| ||
| Hip arthroplasty | Surgical and medical procedures | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Haematoma muscle | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Device related thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Epistaxis | Vascular disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Nerve injury | Nervous system disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman, MD | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
| Nov 9, 2021 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Revision C | Dec 16, 2016 | Nov 9, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2017 | Feb 17, 2022 | SAP_002.pdf |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
|
| France |
|
|
| Switzerland |
|
|
| Germany |
|
|
| Class II |
|
|
| Class III |
|
|
| Class IV |
|
|
|
| Type II ( Insulin treated) |
|
|
| Type II ( Non-Insulin treated) |
|
|
|
|
|
|
|
|
|
|
|
|
| Class IV |
|
| Class IV |
|
| Class IV |
|
| Class IV |
|
| Class IV |
|