Portico Valve-in-Valve Retrospective Registry

Completed

• Conditions: Aortic Valve Failure; Aortic Stenosis; Aortic Valve Stenosis; Aortic Insufficiency
• Interventions: Device: Transcatheter Aortic Valve Replacement

• Registration Number: NCT05002088
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Study Start: 2021-10-21
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Results First Submitted: 2024-06-28
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Results First Posted: 2025-02-28
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exploratory Registry Arm	Transcatheter Aortic Valve Replacement	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.
Primary Analysis Population	Transcatheter Aortic Valve Replacement	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).

Primary Outcome Measures

Name	Time	Method
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.	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.	1 year post index procedure	Composite of all-cause mortality or disabling stroke.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	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)	5 years post index procedure	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Assessment of Clinical Benefit Endpoint - NYHA Class	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.; 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.
Paravalvular Leak as Measured by Core Lab Echocardiography	5 Years	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.
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography	5 Years	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.
Aortic Valve Area as Measured by Core Lab Echocardiography	5 Years	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.
Aortic Valve Area Measured by Core Lab Echocardiography	3 Years	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.
New Pacemaker Implant	1 year	New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.

Trial Locations

Locations (7)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Universitätsklinikum Rostock (AöR); 🇩🇪 Rostock, Germany

GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital; 🇦🇺 Adelaide, Australia

GenesisCare - Wesley Hospital; 🇦🇺 Auchenflower, Australia

Kerckhoff-Klinik gGmbH; 🇩🇪 Bad Nauheim, Germany

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Morriston Hospital - ABM University Health Board; 🇬🇧 Morriston, United Kingdom