Aortic Valve StenosisNCT05002088
Portico Valve-in-Valve Retrospective Registry
An observational study of Aortic Valve Stenosis and Aortic Valve Failure, run by Abbott Medical Devices at 7 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 21 Oct 2021to 29 Dec 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study may enroll up to 100 patients who had a documented failed surgical aortic bioprosthetic valve (due stenosis, insufficiency, or a combination of both) at increased risk for redo surgical aortic valve replacement surgery. Patients must have met the sizing requirements of the Portico transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Patients must meet all inclusion and exclusion criteria to be eligible for enrollment. In addition, an 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. There will be no enrollment limit in the exploratory registry arm
Who may be able to join
- 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.
- 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.
- Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
- 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.
- Subject is ≥ 18 years of age or legal age in host country at the time of consent.
- Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.
- 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.
- Subject had the Portico or FlexNav delivery system enter their vasculature
Who cannot join
- 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).
- 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).
- Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
- Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
- Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
- Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure.
Show all 12Show fewer
- Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure.
- Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis.
- Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
- Surgical aortic bioprosthetic valve was unstable or rocking.
- Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.
- Subject was unable to tolerate antiplatelet or anticoagulant therapy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Australia2 sites
GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital
Adelaide
GenesisCare - Wesley Hospital
Auchenflower, QLD 4066
Germany2 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Universitätsklinikum Rostock (AöR)
Rostock
United Kingdom2 sites
St. Bartholomew's Hospital
London, EC1A 7BE
Morriston Hospital - ABM University Health Board
Morriston
About this study
Official title: Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
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.
Read the detailed description
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.
- Being tested
- Transcatheter Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Transcatheter 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. Receives: Device: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post index procedure
Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
Composite of all-cause mortality or disabling stroke.
Measured: 1 year post index procedure
Secondary outcomes (33)
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
Measured: 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.
Measured: 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.
Measured: 1 year post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Measured: 2 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Measured: 3 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Measured: 4 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start21 Oct 2021
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 71 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002088
- Sponsor's protocol ID
- ABBOTT-CIP-10414
- Status last verified
- Feb 2025
- First submitted
- 27 Jul 2021
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
- ClinicalTrials.gov ID
- NCT05002088
- Acronym / sponsor ID
- ABBOTT-CIP-10414
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Analysis Population | – | Device: Transcatheter Aortic Valve ReplacementThe 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). |
| Exploratory Registry Arm | – | Device: Transcatheter Aortic Valve ReplacementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study may enroll up to 100 patients who had a documented failed surgical aortic bioprosthetic valve (due stenosis, insufficiency, or a combination of both) at increased risk for redo surgical aortic valve replacement surgery. Patients must have met the sizing requirements of the Portico transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Patients must meet all inclusion and exclusion criteria to be eligible for enrollment. In addition, an 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. There will be no enrollment limit in the exploratory registry arm
Key inclusion criteria (8 listed)
- 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.
- 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.
- Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
- 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.
- Subject is ≥ 18 years of age or legal age in host country at the time of consent.
Key exclusion criteria (12 listed)
- 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).
- 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).
- Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
- Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
- Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementTranscatheter 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 | Device | Exploratory Registry Arm, Primary Analysis Population |
Primary outcome
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.
Time frame: 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
Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
Time frame: 1 year post index procedure
Composite of all-cause mortality or disabling stroke.
33 secondary outcomes
Number of Participants With Procedural Success
Time frame: Procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 30 days post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 1 year post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 2 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 3 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 4 years post index procedure
Evaluation of Adverse Event Rates (Descriptive Endpoint)
Time frame: 5 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 30 days post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 1 year post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 2 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 3 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 4 years post index procedure
Assessment of Clinical Benefit Endpoint - NYHA Class
Time frame: 5 years post index procedure
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 30 Days
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 1 Year
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 2 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 3 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 4 Years
Paravalvular Leak as Measured by Core Lab Echocardiography
Time frame: 5 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 30 days
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 1 year
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 2 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 3 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 4 Years
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Time frame: 5 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Time frame: 30 days
Aortic Valve Area as Measured by Core Lab Echocardiography
Time frame: 1 Year
Aortic Valve Area as Measured by Core Lab Echocardiography
Time frame: 2 Years
Aortic Valve Area Measured by Core Lab Echocardiography
Time frame: 3 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Time frame: 4 Years
Aortic Valve Area as Measured by Core Lab Echocardiography
Time frame: 5 Years
New Pacemaker Implant
Time frame: 30 days
New Pacemaker Implant
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barathi Sethuraman study director
Abbott
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Valve Failure, run by Abbott Medical Devices at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Germany, United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.