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The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Experimental | Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included. |
|
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Experimental | Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portico™ Valve, Portico Delivery System(s) and Loading System(s) | Device | Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Mortality | Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause. | 30 days from the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Myocardial Infarction | At 30 days | |
| Number of Subjects With Stroke | At 30 days | |
| Number of Subjects With Bleeding Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helge Möllmann | St. Johannes Hospital, Dortmund, Germany | Principal Investigator |
| Vinny Podichetty | Abbott Structural Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Care Partners- Wesley Hospital | Woolloongabba | Queensland | 4102 | Australia | ||
| AZ Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38283573 | Derived | Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan. |
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Between October 2018 and July 2021, implantation with a Portico™ transcatheter heart valve (THV) was attempted in 1001 subjects. This clinical investigation includes 27 sites in 8 countries across Europe and 1 site in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Portico™ Valve, Delivery System(s) and Loading System(s) | Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. |
| FG001 | Portico™ Valve, FlexNav Delivery and Loading System(s) |
| 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 8, 2019 | Oct 7, 2023 |
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This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
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| Portico™ Valve, FlexNav Delivery System(s) and Loading System(s) | Device | Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. |
|
| At 30 days |
| Number of Subjects With Acute Kidney Injury | The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output <0.5 mL/kg per hour for >6 but <12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output <0.5 mL/kg per hour for >12 but <24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X 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 per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria. | At 30 days |
| Number of Subjects With Vascular Complications | At 30 days |
| Number of Subjects With Annular Rupture | At 30 days |
| Number of Subjects With Coronary Obstruction | At 30 days |
| Number of Subjects Undergoing Conversion To Open Surgery | At 30 days |
| Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment | At 30 days |
| Number Of Subjects With Valve Embolization | At 30 days |
| Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion | At 30 days |
| Vessel Diameter | At 30 days |
| Introducer Sheath Used | This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature). | At 30 days |
| Implant Success | At 30 days |
| Effective Orifice Area | Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph. | At 30 days |
| Aortic Valve Mean Gradient | Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph. | At 30 days |
| Number of Subjects With Paravalvular Leak (PVL) | At 30 days |
| NYHA Classification | NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV). | At 30 days |
| EQ5D-3L Visual Analog Scale Value | The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state." | At 30 days |
| Kaplan-Meier Rate of All-cause Mortality | Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point. | At 12 months |
| Antwerp |
| 2020 |
| Belgium |
| University Hospital Olomouc | Olomouc | 77900 | Czechia |
| Kliniken der Friedrich-Alexander-Universitat | Erlangen | Bavaria | 91054 | Germany |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | 61231 | Germany |
| Universitätsmedizin Berlin - Charité Campus Mitte (CCM) | Berlin | 10117 | Germany |
| Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | 12203 | Germany |
| St.-Johannes-Hospital | Dortmund | 44137 | Germany |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | 01307 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt | 60590 | Germany |
| UKE Hamburg (Universitatsklinik Eppendorf) | Hamburg | 20246 | Germany |
| Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV | Karlsruhe | 76133 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Charite Campus Virchow Klinikum | Mitte | 13353 | Germany |
| Policlinico di Monza | Monza | Lombardy | 20900 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Policlinico San Donato | San Donato Milanese | 20097 | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Samodzielny Publiczny Centralny Szpital Kliniczny | Warsaw | Masovian Voivodeship | 02-097 | Poland |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Catalonia | 08025 | Spain |
| Hospital General Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Royal Victoria Hospital | Belfast | Ireland | BT12 6BA | United Kingdom |
| James Cook University Hoospital | Middlesbrough | North East England | TS4 3BW | United Kingdom |
| Morriston Hospital - ABM University Health Board | Morriston | Swansea | SA6 6NL | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Portico™ Valve, Delivery System(s) and Loading System(s) | Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. |
| BG001 | Portico™ Valve, FlexNav Delivery and Loading System(s) | Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. |
| 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 |
| ||||||||||||||||
| 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 |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| NYHA Classification | New York Heart Association heart failure classification. I - no symptoms and no limitation. II - mild symptoms. III - marked limitation in activity due to symptoms, even during less-than-ordinary activity. IV - severe limitation, experiences symptoms even at rest. | Count of Participants | Participants |
| |||||||||||||||
| Baseline EQ5D-3L Visual Analog Scale Value | EQ5D-3L stands for EuroQol5D-3L. Scale 0-100 (best). Subject selects their rating of their own health on a visual scale from 0-100. Scores were used as a measure of improvement from baseline; subjects served as their own controls. Staging was relative to the unitless baseline score - higher score was better. | The number analyzed in row differs because not all subjects had EQ5D-3L collected at baseline. | Mean | Standard Deviation | units on a scale |
|
| 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 | Cardiovascular Mortality | Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 30 days from the index procedure |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Myocardial Infarction | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Stroke | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Bleeding Events | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Acute Kidney Injury | The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output <0.5 mL/kg per hour for >6 but <12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output <0.5 mL/kg per hour for >12 but <24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X 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 per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria. | Posted | Count of Participants | Participants | At 30 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Vascular Complications | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Annular Rupture | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Coronary Obstruction | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Undergoing Conversion To Open Surgery | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number Of Subjects With Valve Embolization | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion | Subjects with a pacemaker at baseline are not included. | Posted | Count of Participants | Participants | At 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Vessel Diameter | Posted | Mean | Standard Deviation | mm | At 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Introducer Sheath Used | This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature). | Posted | Count of Participants | Participants | At 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Implant Success | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Effective Orifice Area | Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph. | Posted | Mean | Standard Deviation | cm^2 | At 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Aortic Valve Mean Gradient | Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph. | Posted | Mean | Standard Deviation | mmHg | At 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Paravalvular Leak (PVL) | Posted | Count of Participants | Participants | At 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | NYHA Classification | NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV). | Posted | Count of Participants | Participants | At 30 days |
| ||||||||||||||||||||||||||||||||
| Secondary | EQ5D-3L Visual Analog Scale Value | The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state." | Posted | Mean | Standard Deviation | units on a scale | At 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Rate of All-cause Mortality | Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point. | Posted | Number | percentage of All-cause Mortality | At 12 months |
|
|
30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
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 | Portico™ Valve, Delivery System(s) and Loading System(s) | Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. | 16 | 501 | 348 | 501 | 72 | 501 |
| EG001 | Portico™ Valve, FlexNav Delivery and Loading System(s) | Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. | 10 | 500 | 358 | 500 | 80 | 500 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombus | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic Valve Regurgitation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bleeding | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Arrhythmias | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Complete Heart Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnea | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Endocarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| First Degree Heart Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Left Bundle Branch Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mitral Valve Insufficiency | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial Ischemia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Paravalvular Leak | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericardial Tamponade | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural Effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Second Degree Heart Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombus On Device | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Valve Embolization | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anemia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GI Bleed | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ischemia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Weakness | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Multi Organ Failure | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnea | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Fever | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Multi Organ Failure | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Insufficiency/Worsening Renal Function | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary Tract Infection/UTI | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Annulus Rupture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Valve Embolization | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Valve Migration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient Ischemic Attack (TIA) | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Multi Organ Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Insufficiency/Worsening Renal Function | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Access Site Bleeding Event | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bleeding | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death - Unknown | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ischemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Other | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pseudoaneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Access Site And Access Related Complications | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Perforation | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Vessel Occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Bundle Branch Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinny Podichetty, Sr. Director, Global Clinical Affairs | Abbott | +1 408-845-1639 | vinny.podichetty@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2021 | Oct 6, 2023 | SAP_001.pdf |
| 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 |
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