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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.
Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.
During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip G4 System | Device | Percutaneous mitral valve repair using the MitraClip G4 system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days | At 30 days |
| Occurrence of Major Adverse Events (MAE) at 30 Days | MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications. | At 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With APS | Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure | Up to 10 Days |
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 an analysis of all consented subjects who satisfy the inclusion and exclusion criteria and who are treated with the MitraClip G4 System. The study will include approximately 1100 subjects treated with the MitraClip G4 System that have data available for assessment of APS.
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| Name | Affiliation | Role |
|---|---|---|
| Kartik Sundareswaran, PhD | Abbott Structural Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Cardiology Associates of Mobile, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40713981 | Derived | Tang GHL, Price MJ, Rottbauer W, Mahoney PD, Hausleiter J, Raake PW, Rollefson WA, Lurz P, Denti P, Chehab BK, Dong M, Huang R, Asch FM, Zamorano JL, von Bardeleben RS, Maisano F, Kar S, Rodriguez E. Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies. JACC Heart Fail. 2025 Sep;13(9):102565. doi: 10.1016/j.jchf.2025.102565. Epub 2025 Jun 27. | |
| 39619400 |
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| ID | Title | Description |
|---|---|---|
| FG000 | MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 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 | Nov 4, 2020 | May 15, 2023 |
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| Number of Participants With ADS | Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge. | Up to 10 Days |
| Occurrence of In-hospital Major Adverse Events (MAE) | In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed. | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days |
| Rate of All Cause Mortality Through 5 Years | All Cause Mortality Through 5 years | Through 5 years |
| Number of Heart Failure Hospitalization Through 5 Years | Heart Failure Hospitalization through 5 years | Through 5 years |
| Occurrence of MAE | Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years | Through 5 years |
| Rate of Device Related Complications as Defined in the Protocol Through 5 Years | Device Related Complications as defined in the protocol through 5 years | Through 5 years |
| Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year | MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year |
| Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year | MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year |
| Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV) | Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years |
| Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100) | Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year | 30 days, 1, 2, 3, 4 and 5 year |
| Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year | Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year | 30 days, 1, 2, 3, 4 and 5 year |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| University of California - Davis Medical Center | Sacramento | California | 95817 | United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| Cardiology Associates of Fairfield County, PC | Norwalk | Connecticut | 06851 | United States |
| NCH Healthcare System | Naples | Florida | 34102 | United States |
| Northshore University Health System | Evanston | Illinois | 60201 | United States |
| Prairie Education & Research | Springfield | Illinois | 62769 | United States |
| Via Christi | Wichita | Kansas | 67218 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Hudson Valley Cardiovascular Practice, P.C. | Poughkeepsie | New York | 12601 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37236 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23504 | United States |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 2E8 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | H1T 1C8 | Canada |
| CHU Hospital de Pontchaillou | Rennes | France |
| CHU Rangueil Toulouse | Toulouse | France |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Kiel | 24105 | Germany |
| Elisabeth-Krankenhaus Essen GmbH | Essen | North Rhin | 45138 | Germany |
| UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz | Mainz | Rhinela | 55131 | Germany |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Freiburg | Bad Krozingen | Germany |
| Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | 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 | Göttingen | Germany |
| Katholisches Marienkrankenhaus GmbH | Hamburg | 22087 | Germany |
| Klinikum der Ruprecht-Karls-Universität Heidelberg | Heidelberg | Germany |
| Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | Germany |
| Universitatsklinikum Ulm | Ulm | Germany |
| Shaare Zedek Medical Center | Jerusalem | Israel |
| Ospedale San Raffaele- Cardiac | Milan | Lombard | 20132 | Italy |
| Policlinico San Donato | Milan | Lombard | 20132 | Italy |
| Presidio Ospedaliero Ferrarotto Alessi | Catania | Italy |
| Centro Cardiologico Monzino | Milan | Italy |
| Nagoya Heart Center | Nagoya | Aichi-ken | 461-0045 | Japan |
| Gifu Prefectural General Medical Center | Gifu | Gifu | 500-8717 | Japan |
| Hyogo Brain & Heart Center | Himeji | Hyōgo | 670-0981 | Japan |
| Mitsui Memorial Hospital | Tokyo | Kanto | 101-8643 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Kumamoto | 861-4193 | Japan |
| Sendai Kosei Hospital | Sendai | Miyagi | 980-0873 | Japan |
| The Sakakibara Heart Insitute of Okayama | Okayama | Okayama-ken | 700-0804 | Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| Erasmus Mc Rotterdam | Rotterdam | Netherlands |
| Prince Sultan Cardiac Center - Riyadh | Riyadh | 1 | Saudi Arabia |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital Alvaro Cunqueiro Dept of Interventional Cardiology | Vigo | Spain |
| Derived |
| Morikawa T, Enta Y, Sakamoto T, Yamamoto M, Ueno H, Yagasaki H, Asch FM, Dong M, Peterman K, Rodriguez E, von Bardeleben RS, Asami M. 1-Year Outcomes of Fourth-Generation Mitral Transcatheter Edge-to-Edge Repair in Japan From the EXPAND G4 Study. JACC Asia. 2024 Sep 24;4(11):810-821. doi: 10.1016/j.jacasi.2024.08.003. eCollection 2024 Nov. |
| 37877913 | Derived | von Bardeleben RS, Mahoney P, Morse MA, Price MJ, Denti P, Maisano F, Rogers JH, Rinaldi M, De Marco F, Rollefson W, Chehab B, Williams M, Leurent G, Asch FM, Rodriguez E. 1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2600-2610. doi: 10.1016/j.jcin.2023.09.029. Epub 2023 Oct 24. |
| COMPLETED | Participant Flow is for 30 Days |
|
| NOT COMPLETED |
|
|
All 1164 subjects completed the Baseline visit
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| ID | Title | Description |
|---|---|---|
| BG000 | MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 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 | Number | participants |
| ||||||||||||||||||
| Height | All available data has been reported. | Mean | Standard Deviation | cm |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Kg |
| |||||||||||||||||
| Body Mass Index | All available data has been reported | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Euro Score II | EuroSCORE II estimates the 30-day mortality risk after cardiac surgery, expressed as a percentage. EuroSCORE II score has three groups, 1. low risk defined as EuroSCORE < 4%, 2. intermediate risk as 4-8%, and 3. high risk as > 8%. | All available data has been reported | Mean | Standard Deviation | points on a scale |
| |||||||||||||||
| STS Replacement Score | The Society of Thoracic Surgeons (STS) score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. As of November 15, 2018, The STS released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries. | All available data has been reported | Mean | Standard Deviation | percentage |
| |||||||||||||||
| Prior Cardiac Sugeries | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Coronary Revascularization | Count of Participants | Participants |
| ||||||||||||||||||
| Coronary Artery Bypass Graft (CABG) | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Cardiac Interventions (PCI) | Count of Participants | Participants |
| ||||||||||||||||||
| Permanent Pacemaker | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Heart Failure Hospitalization within 1 year | 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 | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days | All available data has been reported | Posted | Count of Participants | Participants | At 30 days |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Occurrence of Major Adverse Events (MAE) at 30 Days | MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications. | All available data has been reported | Posted | Count of Participants | Participants | At 30 days |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With APS | Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure | All available data has been reported. | Posted | Count of Participants | Participants | Up to 10 Days |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ADS | Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge. | All available data has been reported. | Posted | Count of Participants | Participants | Up to 10 Days |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Occurrence of In-hospital Major Adverse Events (MAE) | In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed. | Posted | Count of Participants | Participants | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days |
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of All Cause Mortality Through 5 Years | All Cause Mortality Through 5 years | Not Posted | Through 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Heart Failure Hospitalization Through 5 Years | Heart Failure Hospitalization through 5 years | Not Posted | Through 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Occurrence of MAE | Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years | Not Posted | Through 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Device Related Complications as Defined in the Protocol Through 5 Years | Device Related Complications as defined in the protocol through 5 years | Not Posted | Through 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year | MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year | Not Posted | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year | MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year | Not Posted | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV) | Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years | Not Posted | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100) | Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year | Not Posted | 30 days, 1, 2, 3, 4 and 5 year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year | Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year | Not Posted | 30 days, 1, 2, 3, 4 and 5 year | Participants |
All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
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 | MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system. | 16 | 1,164 | 209 | 1,164 | 0 | 1,164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ATRIAL SEPTAL DEFECT ACQUIRED | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIAC PERFORATION | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| MITRAL PERFORATION | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| MITRAL VALVE STENOSIS | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| TRICUSPID VALVE INCOMPETENCE | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ASTHENIA | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIAC COMPLICATION ASSOCIATED WITH DEVICE | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DEVICE CAPTURING ISSUE | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CARDIAC INFECTION | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| PNEUMOTHORAX TRAUMATIC | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| VASCULAR PROCEDURE COMPLICATION | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| MEAN ARTERIAL PRESSURE DECREASED | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| OXYGEN SATURATION DECREASED | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| METABOLISM AND NUTRITION DISORDERS | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| HYPERKALAEMIA | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| SIMPLE PARTIAL SEIZURES | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| EMBOLISM | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| HAEMORRHAGE | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melody Dong | Abbott | 4086434617 | melody.dong@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2024 | Feb 22, 2024 | 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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| Netherlands |
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| United States |
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| Japan |
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| Italy |
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| Israel |
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| France |
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| Germany |
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| Spain |
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| 3+: Moderate to Severe |
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| 4+: Severe |
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