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| ID | Type | Description | Link |
|---|---|---|---|
| P02C220_JV06EFS_CIP | Other Identifier | JenaValve Technology Inc. | |
| CA-0001 EU | Other Identifier | JenaValve Technology Inc. | |
| CA-0001 Germany | Other Identifier | JenaValve Technology Inc. | |
| CA-0010 | Other Identifier | JenaValve Technology Inc. |
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To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JenaValve Pericardial TAVR System | Device | Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | All-cause mortality rate at 30 Day | 30 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarction | Peri-procedural and spontaneous myocardial infarction | 30 Day |
| All Stroke/TIA | Neurological Complications | 30 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B Leon, MD | New York-Presbyterian Hospital/Columbia University Medical Center, USA | Study Chair |
| Torsten P Vahl, MD | New York-Presbyterian Hospital/Columbia University Medical Center, USA | Principal Investigator |
| Vinod H Thourani, MD | Piedmont Heart Institute, USA | Principal Investigator |
| Hendrik Treede, MD | University Hospital Bonn, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28314623 | Background | Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available. | |
| 28298458 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcatheter Aortic Valve Replacement (TAVR) | Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system. |
| 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 | Jul 15, 2019 |
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| Major Bleeding | Life threatening or major bleeding | 30 Day |
| Major Vascular Complication | Major vascular and bleeding complications | 30 Day |
| Conduction Disturbance and Arrhythmias | Conduction system injury (defect), including AV block, which may require a permanent pacemaker | 30 Day |
| Acute Kidney Injury (AKI) | Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output <0.5 mL/kg/h for >12 but <24 h AKI Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output <0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h | 30 Day |
| Coronary Obstruction Requiring Intervention | Coronary obstruction post-implant requiring intervention | 30 Day |
| Endocarditis | Bacterial endocarditis | 30 Day |
| Conversion to Surgical Aortic Valve Replacement (SAVR) | Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications | 30 Day |
| THV Malpositioning | Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root | 30 Day |
| New York |
| New York |
| 10032 |
| United States |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Herzzentrum der Universität zu Köln | Cologne | 50937 | Germany |
| Universitäts-Herzzentrum Freiburg/Bad Krozingen | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Halle | Halle | 6120 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Leiden University Medical Center | Leiden | 2333 | Netherlands |
| St. Antonius Hospital | Nieuwegein | 3435 | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3062 | Netherlands |
| Auckland City Hospital | Auckland | 1142 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Background |
| Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 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 Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available. |
| 12831818 | Background | Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x. |
| 34556282 | Background | Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available. |
| COMPLETED |
|
| NOT COMPLETED |
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Enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcatheter Aortic Valve Replacement (TAVR) | Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system. |
| 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 |
| |||||||||||||||||
| 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 |
|
| 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 | All-cause mortality rate at 30 Day | Enrolled | Posted | Count of Participants | Participants | 30 Day |
|
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| ||||||||||||||||||||||||||
| Secondary | Myocardial Infarction | Peri-procedural and spontaneous myocardial infarction | Posted | Count of Participants | Participants | 30 Day |
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| Secondary | All Stroke/TIA | Neurological Complications | Posted | Count of Participants | Participants | 30 Day |
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| Secondary | Major Bleeding | Life threatening or major bleeding | Posted | Count of Participants | Participants | 30 Day |
|
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| Secondary | Major Vascular Complication | Major vascular and bleeding complications | Posted | Count of Participants | Participants | 30 Day |
|
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| |||||||||||||||||||||||||||
| Secondary | Conduction Disturbance and Arrhythmias | Conduction system injury (defect), including AV block, which may require a permanent pacemaker | Posted | Count of Participants | Participants | 30 Day |
|
| ||||||||||||||||||||||||||||
| Secondary | Acute Kidney Injury (AKI) | Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output <0.5 mL/kg/h for >12 but <24 h AKI Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output <0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h | Posted | Count of Participants | Participants | 30 Day |
|
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| Secondary | Coronary Obstruction Requiring Intervention | Coronary obstruction post-implant requiring intervention | Posted | Count of Participants | Participants | 30 Day |
|
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| Secondary | Endocarditis | Bacterial endocarditis | Posted | Count of Participants | Participants | 30 Day |
|
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| |||||||||||||||||||||||||||
| Secondary | Conversion to Surgical Aortic Valve Replacement (SAVR) | Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications | Posted | Count of Participants | Participants | 30 Day |
|
| ||||||||||||||||||||||||||||
| Secondary | THV Malpositioning | Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root | Posted | Count of Participants | Participants | 30 Day |
|
|
30 day
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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 | Transcatheter Aortic Valve Replacement (TAVR) | Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system. | 2 | 68 | 39 | 68 | 23 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Disection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Acute Pancreatitis Secondary To Retained Gallstones | Hepatobiliary disorders | Systematic Assessment |
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| Allergic Reaction | General disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aortic Rupture | Cardiac disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Arterial Occlusion | Cardiac disorders | Systematic Assessment |
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| Arterial Occlusive Desease | Cardiac disorders | Systematic Assessment |
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| Bilious Attack | Hepatobiliary disorders | Systematic Assessment |
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| Bleeding (Life Threatening/Disabling) | Blood and lymphatic system disorders | Systematic Assessment |
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| Bleeding (Major) | Blood and lymphatic system disorders | Systematic Assessment |
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| Bleeding Complication | Blood and lymphatic system disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Cellulitus | Infections and infestations | Systematic Assessment |
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| Cerebral Hypoxia Due To Open Heart Surgery. Therefore Cerebral Iscemia Which Was Leading To Death. | Nervous system disorders | Systematic Assessment |
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| Conduction Disturbance | Cardiac disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Ectopic Deployment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Exacerbation COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Exacerbation Of COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fall Secondary To Postural Hypotension | General disorders | Systematic Assessment |
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| Febrile But No Infection Identified | General disorders | Systematic Assessment |
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| Fluid Overload Secondary To Fludricortisone Use | General disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis Norovirus | Gastrointestinal disorders | Systematic Assessment |
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| GI Complication | Gastrointestinal disorders | Systematic Assessment |
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| Heart Failure | Cardiac disorders | Systematic Assessment |
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| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Infection/Inflammation | Infections and infestations | Systematic Assessment |
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| INR > 8 And General Weakness | General disorders | Systematic Assessment |
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| Maxillary Fracture (Le-Fort I Fracture) | General disorders | Systematic Assessment |
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| Medication Reaction | General disorders | Systematic Assessment |
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| Multiple Falls Secondary To Medication And Parkinsons | General disorders | Systematic Assessment |
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| Myocardial Insufficiency | Cardiac disorders | Systematic Assessment |
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| Neurological Event | Nervous system disorders | Systematic Assessment |
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| Other Infection | Infections and infestations | Systematic Assessment |
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| Pancolitis | Gastrointestinal disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Premature Valve Deployment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pseudomonas Bacteremia | Infections and infestations | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Recurring Subdural Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Reduced Mobility | General disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Restenosis | Cardiac disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Spondylolisthesis/Foraminal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Status Epilepticus | Nervous system disorders | Systematic Assessment |
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| Stroke/TIA | Nervous system disorders | Systematic Assessment |
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| Subacute Cerebal Infarct Bilaterally. | Nervous system disorders | Systematic Assessment |
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| Subdural Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Suspected Endocarditis | Infections and infestations | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Tooth Extraction | General disorders | Systematic Assessment |
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| Urosepsis | Infections and infestations | Systematic Assessment |
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| Valve Malposition / Ectopic Deployment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular Dissection | Vascular disorders | Systematic Assessment |
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| Worsening Of Atrial Fibrilation | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Complication | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Respiratory Complication | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinny Podichetty, Vice President: Clinical & Med Affairs | JenaValve Technologies Inc. | 949-767-2110 | 1050 | podichetty@jenavalve.com |
| Sep 6, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
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