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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices.
The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required.
Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip NTR/XTR System | Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip NTR/XTR System | Device | Percutaneous mitral valve repair using the MitraClip NTR/XTR system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measure: Number of Participants With Major Adverse Events (MAE) | MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated). | At 30 Days |
| Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ | The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits. | At 30 days |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects participating in another clinical study that may impact the follow-up or results of this study
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This study will include patients who will undergo commercial procedures with the MitraClip® NTR System and/or MitraClip® XTR System after required approval of the device is obtained.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Saibal Kar, MD | Cedars Sinai, Los Angeles CA | Principal Investigator |
| Prof. Francesco Maisano, MD | University Hospital, Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Princeton | Birmingham | Alabama | 35211 | United States | ||
| Phoenix Cardiovascular Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36922046 | Derived | Kar S, von Bardeleben RS, Rottbauer W, Mahoney P, Price MJ, Grasso C, Williams M, Lurz P, Ahmed M, Hausleiter J, Chehab B, Zamorano JL, Asch FM, Maisano F. Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):589-602. doi: 10.1016/j.jcin.2023.01.010. | |
| 36599332 |
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A total of 1045 subjects were screened between April 5, 2018 and March 29, 2019, of which 4 subjects did not have any procedure attempted.
A total of 1041 subjects attempted MitraClip procedure as of the cut-off date of August 5, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | MitraClip NTR/XTR System | Percutaneous mitral valve repair using the MitraClip NTR and XTR 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 | Yes | No | No | Study Protocol | Jun 26, 2018 | Nov 18, 2021 |
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| Phoenix |
| Arizona |
| 85001 |
| United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California - Davis Medical Center | Sacramento | California | 95817 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80309 | United States |
| JFK Medical Center | West Palm Beach | Florida | 33401 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60007 | United States |
| Via Christi Regional Medical Center - St. Francis Campus | Kansas City | Kansas | 67218 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64102 | United States |
| Atlantic Health System - Morristown Memorial Hospital | Morristown | New Jersey | 07960 | United States |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10001 | United States |
| Mount Sinai Hospital | New York | New York | 10011 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Christ Hospital | Cincinnati | Ohio | 41073 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37236 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23504 | United States |
| University of Washington Medical Center | Seattle | Washington | 98101 | United States |
| München Grosshadern | München | Bavaria | 81377 | Germany |
| UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz | Mainz | Rhinela | 55131 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | Saxony | 04289 | Germany |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | Germany |
| Deutsches Herzzentrum Berlin | Berlin | Germany |
| Immanuelklinikum Bernau und Herzzentrum Brandenburg | Bernau | Germany |
| Medizinische Einrichtungen der Universitat zu Koln | Cologne | Germany |
| St.-Johannes-Hospital | Dortmund | Germany |
| Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | Germany |
| Klinikum der Justus-Liebig-Universität | Giessen | Germany |
| Universitatsmedizin Gottingen Georg-August-Universitat | Göttingen | Germany |
| Katholisches Marienkrankenhaus GmbH | Hamburg | 22087 | Germany |
| Klinikum der Ruprecht-Karls-Universität Heidelberg | Heidelberg | Germany |
| Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG. | Karlsburg | Germany |
| Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany |
| Klinikum Rechts Der Isar der Technischen Universitat Munchen | München | Germany |
| Niels-Stensen-Kliniken Marienhospital Osnabrück | Osnabrück | Germany |
| Universitatsklinikum Ulm | Ulm | Germany |
| Hadassah - Ein Kerem | Jerusalem | Israel |
| Shaare Zedek Medical Center | Jerusalem | Israel |
| Ospedale San Raffaele- Cardiac | Milan | Lombard | 20132 | Italy |
| Ospedale San Raffaele | Milan | Lombard | 20132 | Italy |
| Policlinico San Donato | Milan | Lombard | 20132 | Italy |
| Presidio Ospedaliero Ferrarotto Alessi | Catania | Sicily | 95124 | Italy |
| Centro Cardiologico Monzino | Milan | Italy |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital Puerta de Hierro - Hospital Universitario | Madrid | Spain |
| HCU Virgen de la Victoria | Málaga | Spain |
| Kantonsspital | Aarau | Switzerland |
| Inselspital - University Hospital of Bern | Bern | 3010 | Switzerland |
| Universitaets Spital Zuerich | Zurich | 8091 | Switzerland |
| Royal Brompton Hospital | London | United Kingdom |
| Shuvy M, von Bardeleben RS, Grasso C, Raake P, Lurz P, Zamorano JL, Asch F, Kar S, Maisano F; EXPAND Investigators. Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. ESC Heart Fail. 2023 Apr;10(2):1122-1132. doi: 10.1002/ehf2.14273. Epub 2023 Jan 4. |
| 36075643 | Derived | Sodhi N, Asch FM, Ruf T, Petrescu A, von Bardeleben RS, Lim DS, Maisano F, Kar S, Price MJ. Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1723-1730. doi: 10.1016/j.jcin.2022.07.023. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled subjects who underwent a MitraClip implant.
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| ID | Title | Description |
|---|---|---|
| BG000 | MitraClip NTR/XTR System | Percutaneous mitral valve repair using the MitraClip NTR and XTR 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/Gender, Customized | 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 |
| ||||||||||||||||||
| Cardiac Intervention History: Prior Cardiac Surgeries | 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 | Safety Measure: Number of Participants With Major Adverse Events (MAE) | MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | At 30 Days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ | The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | At 30 days |
|
|
1 year
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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 | MitraClip NTR/XTR System | Percutaneous mitral valve repair using the MitraClip NTR and XTR system | 157 | 1,041 | 392 | 1,041 | 0 | 1,041 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIAS NONHAEMOLYTIC AND MARROW DEPRESSION | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| HAEMOLYSES AND RELATED CONDITIONS | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC ARRHYTHMIAS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| CARDIAC DISORDER SIGNS AND SYMPTOMS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| CARDIAC VALVE DISORDERS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| CORONARY ARTERY DISORDERS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| HEART FAILURES | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| MYOCARDIAL DISORDERS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| PERICARDIAL DISORDERS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| CARDIAC AND VASCULAR DISORDERS CONGENITAL | Congenital, familial and genetic disorders | MedDRA 15.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGES NEC | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| GASTROINTESTINAL SIGNS AND SYMPTOMS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| GASTROINTESTINAL STENOSIS AND OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS COMPLICATIONS ASSOCIATED WITH DEVICE | General disorders | MedDRA 15.0 | Systematic Assessment |
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| DEVICE ISSUES | General disorders | MedDRA 15.0 | Systematic Assessment |
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| FATAL OUTCOMES | General disorders | MedDRA 15.0 | Systematic Assessment |
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| GENERAL SYSTEM DISORDERS NEC | General disorders | MedDRA 15.0 | Systematic Assessment |
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| HEPATIC AND HEPATOBILIARY DISORDERS | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| INFECTIONS - PATHOGEN UNSPECIFIED | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| INJURIES NEC | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| PROCEDURAL RELATED INJURIES AND COMPLICATIONS NEC | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| CARDIAC AND VASCULAR INVESTIGATIONS | Investigations | MedDRA 15.0 | Systematic Assessment |
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| HAEMATOLOGY INVESTIGATIONS | Investigations | MedDRA 15.0 | Systematic Assessment |
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| ELECTROLYTE AND FLUID BALANCE CONDITIONS | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| GASTROINTESTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| LEUKAEMIAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| LYMPHOMAS NON-HODGKIN'S B-CELL | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| MISCELLANEOUS AND SITE UNSPECIFIED NEOPLASMS MALIGNANT AND UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| REPRODUCTIVE NEOPLASMS MALE MALIGNANT AND UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| RESPIRATORY AND MEDIASTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| ENCEPHALOPATHIES | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| MENTAL IMPAIRMENT DISORDERS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| NEUROLOGICAL DISORDERS NEC | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| NEPHROPATHIES | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| RENAL DISORDERS | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| URINARY TRACT SIGNS AND SYMPTOMS | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| BRONCHIAL DISORDERS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| LOWER RESPIRATORY TRACT DISORDERS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| PLEURAL DISORDERS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| PULMONARY VASCULAR DISORDERS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| RESPIRATORY DISORDERS NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| CARDIAC THERAPEUTIC PROCEDURES | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
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| SOFT TISSUE THERAPEUTIC PROCEDURES | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
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| ANEURYSMS AND ARTERY DISSECTIONS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| ARTERIOSCLEROSIS, STENOSIS, VASCULAR INSUFFICIENCY AND NECROSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| DECREASED AND NONSPECIFIC BLOOD PRESSURE DISORDERS AND SHOCK | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| EMBOLISM AND THROMBOSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| VASCULAR DISORDERS NEC | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| VASCULAR HAEMORRHAGIC DISORDERS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| VASCULAR HYPERTENSIVE DISORDERS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| VASCULAR INJURIES | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia Bouhdi | Abbott | 32-479-94-10-37 | nadia.bouhdi@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2020 | Nov 18, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Israel |
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| United Kingdom |
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| Spain |
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| Netherlands |
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| Switzerland |
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| Italy |
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| Title | Measurements |
|---|---|
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| Non-elective CV surgeries for device-related complications |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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