- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002088
Portico Valve-in-Valve Retrospective Registry
Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Karine Miquel, PhD
- Phone Number: +32479600107
- Email: karine.miquel@abbott.com
Study Contact Backup
- Name: Nels Engblom
- Phone Number: (319) 853-3946
- Email: nels.engblom1@abbott.com
Study Locations
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Adelaide, Australia
- GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital
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Auchenflower, Australia, QLD 4066
- GenesisCare - Wesley Hospital
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Copenhagen, Denmark
- Rigshospitalet
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Bad Nauheim, Germany
- Kerckhoff-Klinik gGmbH
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Rostock, Germany
- Universitätsklinikum Rostock (AöR)
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London, United Kingdom, EC1A 7BE
- St. Bartholomew's Hospital
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Morriston, United Kingdom
- Morriston Hospital - ABM University Health Board
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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).
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
Time Frame: 30 days post index procedure
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Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications
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30 days post index procedure
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The rate of all-cause mortality and disabling stroke adverse events at 1-year post-procedure.
Time Frame: 1 year post index procedure
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Composite of all-cause mortality or disabling stroke
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1 year post index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Procedure Success (descriptive endpoint)
Time Frame: Procedure
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Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system
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Procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 30 days post index procedure
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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
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30 days post index procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 1 year post index procedure
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), New pacemaker implant (PPI), Coronary obstruction
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1 year post index procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 2 years post index procedure
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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2 years post index procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 3 years post index procedure
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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3 years post index procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 4 years post index procedure
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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4 years post index procedure
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Evaluation of adverse event rates (descriptive endpoint)
Time Frame: 5 years post index procedure
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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5 years post index procedure
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Clinical Benefit Endpoint
Time Frame: 30 days post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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30 days post index procedure
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Clinical Benefit Endpoint
Time Frame: 1 year post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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1 year post index procedure
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Clinical Benefit Endpoint
Time Frame: 2 years post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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2 years post index procedure
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Clinical Benefit Endpoint
Time Frame: 3 years post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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3 years post index procedure
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Clinical Benefit Endpoint
Time Frame: 4 years post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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4 years post index procedure
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Clinical Benefit Endpoint
Time Frame: 5 years post index procedure
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Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years
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5 years post index procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vinny Podichetty, Abbott
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABBOTT-CIP-10414
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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