The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Study Type
OBSERVATIONAL
Enrollment
71
Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital
Adelaide, Australia
GenesisCare - Wesley Hospital
Auchenflower, Australia
Rigshospitalet
Copenhagen, Denmark
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication.
Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications
Time frame: 30 days post index procedure
Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
Composite of all-cause mortality or disabling stroke.
Time frame: 1 year post index procedure
Number of Participants With Procedural Success
Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system
Time frame: Procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.
Time frame: 30 days post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis.
Time frame: 1 year post index procedure
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Universitätsklinikum Rostock (AöR)
Rostock, Germany
St. Bartholomew's Hospital
London, United Kingdom
Morriston Hospital - ABM University Health Board
Morriston, United Kingdom
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 2 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 3 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 4 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 5 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 30 days post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 1 year post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 2 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 3 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 4 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 5 years post index procedure
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 30 Days
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 1 Year
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 2 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 3 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 4 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 5 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 30 days
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 1 year
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 2 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 3 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 4 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 5 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 30 days
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 1 Year
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 2 Years
Aortic Valve Area Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 3 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 4 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 5 Years
New Pacemaker Implant
New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
Time frame: 30 days
New Pacemaker Implant
New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
Time frame: 1 year