Brief Title
Portico Valve-in-Valve Retrospective Registry
Official Title
Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
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.
Study Type
Observational [Patient Registry]
Primary Outcome
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.
Secondary Outcome
Procedure Success (descriptive endpoint)
Condition
Aortic Valve Stenosis
Intervention
Transcatheter Aortic Valve Replacement
Study Arms / Comparison Groups
Primary Analysis Population
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
October 21, 2021
Completion Date
June 2027
Primary Completion Date
September 2022
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. 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.
3. Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery
to replace the surgical aortic bioprosthetic valve.
4. 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.
5. Subject is ≥ 18 years of age or legal age in host country at the time of consent.
6. Prior to the Portico ViV index procedure, the subject had New York Heart Association
(NYHA) class II, III, or IV.
7. 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.
8. Subject had the Portico or FlexNav delivery system enter their vasculature
Exclusion Criteria:
1. 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).
2. 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).
3. Subject was considered hemodynamically unstable at the time of the ViV procedure
(requiring inotropic support or mechanical heart assistance)
4. Subject had severe ventricular dysfunction with left ventricular ejection fraction
(LVEF) <20% as measured by resting echocardiogram.
5. Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
6. Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3
months prior to ViV index procedure.
7. Subject had a documented history of a cerebrovascular accident (CVA) or a transient
ischemic attack (TIA) ≤6 months prior to index procedure.
8. Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end
stage renal disease requiring chronic dialysis.
9. Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the
index procedure.
10. Surgical aortic bioprosthetic valve was unstable or rocking.
11. Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification)
that made insertion and endovascular access to the aortic valve impossible.
12. Subject was unable to tolerate antiplatelet or anticoagulant therapy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tanya Schikorr, +32479600107, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT05002088
Organization ID
ABBOTT-CIP-10414
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Tanya Schikorr, Study Director, Abbott
Verification Date
June 2022