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The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.
Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | All subjects will receive the Trifecta GT valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifecta GT (Glide Technology) Valve | Device | Surgical aortic valve replacement with Trifecta GT Valve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation | Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate. | 5 years post implant |
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom From All-cause Mortality | Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate. | 5 years post implant |
| Freedom From Valve Related Mortality | Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barathi Sethuraman | Abbott Structural Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Mission Health & Hospitals |
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A total of 358 subjects were enrolled across 27 investigational sites in 12 North American and European countries. The Trifecta GT PMCF study is a single-arm, prospective, multi-center clinical investigation designed to evaluate the five-year safety and performance of the Trifecta GT valve in patients indicated for aortic valve replacement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | All subjects will receive the Trifecta GT valve. Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve. |
| 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 | May 15, 2018 | Jan 25, 2024 |
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| 5 years post implant |
| Freedom From Structural Valve Deterioration | Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation. | 5 years post implant |
| Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration | Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate. | 5 years post implant |
| Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months | LVEF is a measurement of the percentage of blood leaving the heart each time it contracts. | 6 Months |
| Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months | EOA measures the functional valve opening for blood flow through the valve. | 6 Months |
| Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months | iEOA adjusts the EOA measurement to the patient's body size. | 6 Months |
| Valve Hemodynamic Performance for Mean Gradient at Six Months | Mean Gradient measures the average pressure difference across the valve during blood flow. | 6 Months |
| Valve Hemodynamic Performance for Peak Gradient at Six Months | Peak Gradient measures the maximum pressure difference across the valve during blood flow. | 6 Months |
| Asheville |
| North Carolina |
| 28801 |
| United States |
| Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| CHI St. Luke's Health Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Cliniques Universitaires Saint Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Saint John Regional Hospital - New Brunswick Heart Centre | Saint John | New Brunswick | E2L4L2 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Institut de Cardiologie de Montreal | Montreal | Quebec | H1T 1C8 | Canada |
| Tartu University Hospital | Tartu | 50406 | Estonia |
| CHRU Hopital de Pontchaillou | Rennes | Brittany Region | 35033 | France |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | Hesse | 61231 | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | Rhineland-Palatinate | 54292 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | Saxony | 04289 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| Deutsches Herzzentrum Berlin | Berlin | 65760 | Germany |
| Asklepios Klinik Harburg | Hamburg | 21075 | Germany |
| Ospedale Niguarda Ca'Granda | Milan | Lombardy | 20162 | Italy |
| Az. Osp Universitaria Careggi | Florence | Tuscany | 51034 | Italy |
| Ospedale dell'Angelo | Mestre | Veneto | 30174 | Italy |
| Catharina Ziekenhuis | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| Centralny Szpital Kliniczny MSW w Warszawie | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Hospital de São João | Porto | 4202-451 | Portugal |
| Hospital Universitario del Vinalopó | Elche | Alicante | 03293 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Island | 07120 | Spain |
| Plymouth Hospitals NHS Trust - Derriford Hospital | Plymouth | South West England | PL6 8DH | United Kingdom |
| St. Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | All subjects will receive the Trifecta GT valve Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve. |
| 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 |
| |||||||||||||||||
| Hypertension | 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 | Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation | Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate. | Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post implant |
|
|
| |||||||||||||||||||||||||
| Other Pre-specified | Freedom From All-cause Mortality | Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate. | Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018 | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post implant |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Freedom From Valve Related Mortality | Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years. | Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post implant |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Freedom From Structural Valve Deterioration | Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation. | Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post implant |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration | Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate. | Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post implant |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months | LVEF is a measurement of the percentage of blood leaving the heart each time it contracts. | Analysis population includes all study participants with an LVEF assessment at 6 months. | Posted | Mean | Standard Deviation | percentage | 6 Months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months | EOA measures the functional valve opening for blood flow through the valve. | Analysis population includes all study participants with an EOA assessment at 6 months. | Posted | Mean | Standard Deviation | cm^2 | 6 Months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months | iEOA adjusts the EOA measurement to the patient's body size. | Analysis population includes all study participants with an iEOA assessment at 6 months. | Posted | Mean | Standard Deviation | cm^2/m^2 | 6 Months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Valve Hemodynamic Performance for Mean Gradient at Six Months | Mean Gradient measures the average pressure difference across the valve during blood flow. | Analysis population includes all study participants with a mean gradient assessment at 6 months. | Posted | Mean | Standard Deviation | mmHg | 6 Months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Valve Hemodynamic Performance for Peak Gradient at Six Months | Peak Gradient measures the maximum pressure difference across the valve during blood flow. | Analysis population includes all study participants with a peak gradient assessment at 6 months. | Posted | Mean | Standard Deviation | mmHg | 6 Months |
|
|
5 Years
All AEs reported in the Trifecta GT PMCF study.
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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 | Treatment | All subjects will receive the Trifecta GT valve Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve. | 54 | 358 | 206 | 358 | 82 | 358 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - OTHER BLEEDING | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| EMBOLISM | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| ENDOCARDITIS | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| NONSTRUCTURAL DYSFUNCTION | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| STRUCTURAL VALVE DETERIORATION | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Ear and labyrinth disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Endocrine disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Eye disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Eye disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - GASTROINTESTINAL BLEED | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | General disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | General disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Hepatobiliary disorders | MedDRA (11) | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Infections and infestations | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Infections and infestations | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Injury, poisoning and procedural complications | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - OTHER BLEEDING | Injury, poisoning and procedural complications | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Injury, poisoning and procedural complications | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Injury, poisoning and procedural complications | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Metabolism and nutrition disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Metabolism and nutrition disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Musculoskeletal and connective tissue disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | Systematic Assessment |
| |
| EMBOLISM | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - OTHER BLEEDING | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Psychiatric disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Psychiatric disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - UROLOGIC BLEEDING | Renal and urinary disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Renal and urinary disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Reproductive system and breast disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Skin and subcutaneous tissue disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Social circumstances | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Surgical and medical procedures | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Surgical and medical procedures | MedDRA (11) | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - OTHER BLEEDING | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OTHER CARDIOVASCULAR | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
| |
| NONSTRUCTURAL DYSFUNCTION | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| STRUCTURAL VALVE DETERIORATION | Cardiac disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Eye disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - GASTROINTESTINAL BLEED | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | General disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | General disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Infections and infestations | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Metabolism and nutrition disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Musculoskeletal and connective tissue disorders | MedDRA (11) | Systematic Assessment |
| |
| EMBOLISM | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NEUROVASCULAR | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Nervous system disorders | MedDRA (11) | Systematic Assessment |
| |
| NONSTRUCTURAL DYSFUNCTION | Product Issues | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Product Issues | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Psychiatric disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Renal and urinary disorders | MedDRA (11) | Systematic Assessment |
| |
| MAJOR BLEEDING - OTHER BLEEDING | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Skin and subcutaneous tissue disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER CARDIOVASCULAR | Vascular disorders | MedDRA (11) | Systematic Assessment |
| |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
The PI may not publish study results until publication of results of multi center study or 2 years after study completion, whichever is sooner. PI allows Sponsor to review any proposed publication at least 40 days before forwarding it to any person that is not bound by confidentiality agreement between Sponsor and PI. Sponsor can request delay publication for no more than 120 days to allow Sponsor to file patent applications or take other measures to preserve or secure its Intellectual Property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karine Miquel, Associate Director of Project Management | Abbott | +32 479 600 107 | karine.miquel@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2022 | Jan 25, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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