Portico Valve-in-Valve Retrospective Registry
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Analysis Population The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). |
Device: Transcatheter Aortic Valve Replacement
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
|
| Exploratory Registry Arm The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. |
Device: Transcatheter Aortic Valve Replacement
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
|
Outcome Measures
Primary Outcome Measures
- The rate of all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complication adverse events at 30-days post-procedure. [30 days post index procedure]
Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications
- The rate of all-cause mortality and disabling stroke adverse events at 1-year post-procedure. [1 year post index procedure]
Composite of all-cause mortality or disabling stroke
Secondary Outcome Measures
- Procedure Success (descriptive endpoint) [Procedure]
Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system
- Evaluation of adverse event rates (descriptive endpoint) [30 days post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), New pacemaker implant (PPI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular, access-related, or cardiac structure complication, acute kidney injury (AKI) stages 1-4
- Evaluation of adverse event rates (descriptive endpoint) [1 year post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), New pacemaker implant (PPI), Coronary obstruction
- Evaluation of adverse event rates (descriptive endpoint) [2 years post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
- Evaluation of adverse event rates (descriptive endpoint) [3 years post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
- Evaluation of adverse event rates (descriptive endpoint) [4 years post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
- Evaluation of adverse event rates (descriptive endpoint) [5 years post index procedure]
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
- Clinical Benefit Endpoint [30 days post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
- Clinical Benefit Endpoint [1 year post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
- Clinical Benefit Endpoint [2 years post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
- Clinical Benefit Endpoint [3 years post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
- Clinical Benefit Endpoint [4 years post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
- Clinical Benefit Endpoint [5 years post index procedure]
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.
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Surgical bioprosthesis true inner diameter (true ID) was ≥ 19 mm and ≤ 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing.
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Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
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Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection.
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Subject is ≥ 18 years of age or legal age in host country at the time of consent.
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Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.
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Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system.
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Subject had the Portico or FlexNav delivery system enter their vasculature
Exclusion Criteria:
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Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
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Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).
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Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
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Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
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Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
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Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure.
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Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure.
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Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis.
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Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
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Surgical aortic bioprosthetic valve was unstable or rocking.
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Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.
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Subject was unable to tolerate antiplatelet or anticoagulant therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GenesisCare - Wesley Hospital | Auchenflower | Australia | QLD 4066 | |
| 2 | Rigshospitalet | Copenhagen | Denmark | ||
| 3 | Kerckhoff-Klinik gGmbH | Bad Nauheim | Germany | ||
| 4 | St. Bartholomew's Hospital | London | United Kingdom | EC1A 7BE | |
| 5 | Morriston Hospital - ABM University Health Board | Morriston | United Kingdom |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Tanya Schikorr, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABBOTT-CIP-10414