Clinical trial NCT05002088: Portico Valve-in-Valve Retrospective Registry
Official title: Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Aortic Valve Failure
Aortic Insufficiency
Aortic Stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

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

Primary outcomes:
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.
timeFrame: 30 days post index procedure
measure: Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
timeFrame: 1 year post index procedure
Secondary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: Procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 30 days post index procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 1 year post index procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 2 years post index procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 3 years post index procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 4 years post index procedure
measure: Evaluation of Adverse Event Rates (Descriptive Endpoint)
timeFrame: 5 years post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 30 days post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 1 year post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 2 years post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 3 years post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 4 years post index procedure
measure: Assessment of Clinical Benefit Endpoint - NYHA Class
timeFrame: 5 years post index procedure
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 30 Days
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 1 Year
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 2 Years
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 3 Years
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 4 Years
measure: Paravalvular Leak as Measured by Core Lab Echocardiography
timeFrame: 5 Years
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 30 days
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 1 year
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 2 Years
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 3 Years
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 4 Years
measure: Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
timeFrame: 5 Years
measure: Aortic Valve Area as Measured by Core Lab Echocardiography
timeFrame: 30 days
measure: Aortic Valve Area as Measured by Core Lab Echocardiography
timeFrame: 1 Year
measure: Aortic Valve Area as Measured by Core Lab Echocardiography
timeFrame: 2 Years
measure: Aortic Valve Area Measured by Core Lab Echocardiography
timeFrame: 3 Years
measure: Aortic Valve Area as Measured by Core Lab Echocardiography
timeFrame: 4 Years
measure: Aortic Valve Area as Measured by Core Lab Echocardiography
timeFrame: 5 Years
measure: New Pacemaker Implant
timeFrame: 30 days
measure: New Pacemaker Implant
timeFrame: 1 year
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital
city: Auchenflower
country: Australia
facility: GenesisCare - Wesley Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock (AöR)
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Morriston
country: United Kingdom
facility: Morriston Hospital - ABM University Health Board
Study officials:
affiliation: Abbott
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: