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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000632-26 | EudraCT Number |
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The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
|
| Unfractionated heparin (UFH) | Active Comparator | The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge | Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:
| at 48 hours or discharge, whichever occurs first |
| Net Adverse Clinical Events (NACE) at up to 30 Days | The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. | up to 30 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| NACE at 48 Hours or Before Hospital Discharge | NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH
Refusal to receive blood transfusion
Mechanical valve (any location) or mitral bioprosthetic valve
Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm)
Use of elective surgical cut-down for transfemoral access
Concurrent performance of percutaneous coronary intervention with TAVR
International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis
History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation
Severe left ventricular dysfunction (left ventricular ejection fraction <15%)
Severe aortic regurgitation or mitral regurgitation (4+)
Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure
Dialysis dependent
Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure
Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days
Percutaneous coronary intervention within 30 days
Upper gastrointestinal or genitourinary bleed within 30 days
Stroke or transient ischemic attack within 30 days
Any surgery or biopsy within 2 weeks
Administration of:
Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast
Contraindications or allergy to aspirin or clopidogrel
Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy
Previous enrollment in this study
Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Lefevre, MD | Hôpital Privé Jacques Cartier | Principal Investigator |
| Eberhardt Grube, MD | University Hospital, Bonn | Principal Investigator |
| George D Dangas, MD, PhD | The Zena and Michael A. Wiener Cardiovascular Institute | Study Director |
| Prodromos Anthopoulos, MD | The Medicines Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada | ||
| St. Paul´s Hospital Providence Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27208464 | Derived | Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18. | |
| 26477635 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bivalirudin | Bivalirudin administered as a bolus and intravenous (IV) infusion during transcatheter aortic valve replacement (TAVR). It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Unfractionated Heparin | Drug | Unfractionated heparin is an anticoagulant. |
|
|
| at 48 hours or before hospital discharge, whichever occurred earlier |
| Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke | The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented. | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
| Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS) | Percentage of participants with major bleeding according to the following scales:
| at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
| Transient Ischemic Attack | The percentage of participants reporting transient ischemic attack is presented. | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
| Acute Kidney Injury | The percentage of participants reporting acute kidney injury is presented. | at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
| Major Vascular Complications | The percentage of participants reporting a major vascular complications as defined by VARC is presented. | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
| Acquired Thrombocytopenia | The percentage of participants reporting acquired thrombocytopenia is presented. | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
| New Onset Atrial Fibrillation/Flutter | The percentage of participants reporting new onset atrial fibrillation/flutter is presented. | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
| Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge | The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented. | Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations) |
| Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor | The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented. | at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
| Vancouver |
| V6Z1Y6 |
| Canada |
| Clinique Pasteur, Unité de Cardiologie Interventionnelle | Toulouse | Cedex 3 | 31076 | France |
| CHU de Toulouse | Toulouse | Cedex 9 | 31059 | France |
| CHU Jean Minjoz, Service de Cardiologie | Besançon | 25000 | France |
| Centre Hospitalier de Lyon | Bron | 69500 | France |
| Department of Cardiology, CHRU Lille | Lille | 59037 | France |
| Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle | Rouen | 76031 | France |
| University Heart Centre, Clinic of Inner Medicine 1 Cardiology | Jena | Lobeda Ost | 07747 | Germany |
| Universitätsklinikum Bonn | Bonn | 53105 | Germany |
| Klinikum links der Weser Bremen | Bremen | 28277 | Germany |
| Elisabeth-Krankenhaus Essen | Essen | 45257 | Germany |
| Freiburg University | Freiburg im Breisgau | 79106 | Germany |
| Asklepios St. Georg Hamburg | Hamburg | 20099 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universität Leipzig - Herzzentrum GmbH | Leipzig | 04289 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | 55131 | Germany |
| LMU Munich, Klinikum der Universität München | Munich | 81377 | Germany |
| Deutsches Herzzentrum München | München | 80636 | Germany |
| Helios Heart Center Siegburg | Siegburg | 53721 | Germany |
| Ferraroto Hospital, University of Catania | Catania | 95123 | Italy |
| Ospedale San Raffaele U.O. Cardiologia Interventistica | Milan | 20132 | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | 56124 | Italy |
| Azienda Ospedaliera San Camillo-Forlanini | Roma | 00151 | Italy |
| Policlinico Umberto I, Università La Sapienza | Roma | Italy |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Cardiology University Hospital Basel | Basel | CH-4031 | Switzerland |
| Universitätsklinik Bern | Bern | 3010 | Switzerland |
| The Royal Sussex County Hospital | Brighton | East Sussex | BN2 5BE | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Derived |
| Dangas GD, Lefevre T, Kupatt C, Tchetche D, Schafer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15. |
| FG001 | Unfractionated Heparin (UFH) | The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
| Intent-To-Treat (ITT) Population |
|
| Received at Least 1 Dose of Study Drug |
|
| BRAVO 2 Feasibility Cohort |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bivalirudin | Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
| BG001 | Unfractionated Heparin (UFH) | The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge | Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:
| Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or discharge, whichever occurs first |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Net Adverse Clinical Events (NACE) at up to 30 Days | The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. | Participants in the ITT population. | Posted | Number | percentage of participants | up to 30 days after procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | NACE at 48 Hours or Before Hospital Discharge | NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier |
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| Secondary | Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke | The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS) | Percentage of participants with major bleeding according to the following scales:
| Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Transient Ischemic Attack | The percentage of participants reporting transient ischemic attack is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Kidney Injury | The percentage of participants reporting acute kidney injury is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Vascular Complications | The percentage of participants reporting a major vascular complications as defined by VARC is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acquired Thrombocytopenia | The percentage of participants reporting acquired thrombocytopenia is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | New Onset Atrial Fibrillation/Flutter | The percentage of participants reporting new onset atrial fibrillation/flutter is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge | The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented. | Participants in the ITT population with an incidence of major bleeding. Participants were categorized as "First half of study site's enrolled participants" (Bivalirudin, N=173; UFH, N=173) and "Second half of study site's enrolled participants" (Bivalirudin, N=171; UFH, N=165). Only sites with >20 participants are included in this analysis. | Posted | Number | percentage of participants | Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor | The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented. | Participants in the ITT population. | Posted | Number | percentage of participants | at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up |
|
|
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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 | Bivalirudin | Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. | 112 | 393 | 73 | 393 | ||
| EG001 | Unfractionated Heparin (UFH) | The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. | 116 | 394 | 70 | 394 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Femoral artery dissection | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal anastomosis | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Device leakage | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Thrombosis in device | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Device dislocation | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| General physical health deterioration | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Hyperthermia | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Sudden death | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac valve replacement | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac valve rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bifascicular block | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac perforation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Low cardiac output syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bundle branch block | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Intestinal infarction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Klebsiella infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pseudomonas infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Septic encephalopathy | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment | Organ system includes administration site conditions. |
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| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Health Science Center | The Medicines Company | 800-388-1183 |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
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| Netherlands |
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| Italy |
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| United Kingdom |
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| France |
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| Switzerland |
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| Germany |
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Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis. |
| OG002 | UFH: First Half of Study Site's Enrolled Participants | The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis. |
| OG003 | UFH: Second Half of Study Site's Enrolled Participants | The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site's enrolled participants, and only sites with more than 20 participants are included in this analysis. |
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