Portico Valve-in-Valve Retrospective Registry

NCT05002088 | Completed Results FDA Device

• 1 other identifier: ABBOTT-CIP-10414
• Study Type: observational
• Target: 71
• Locations: 4 countries
• Sites: 7

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Failure; Aortic Insufficiency; Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

  30 days post index procedure

• Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.

  Composite of all-cause mortality or disabling stroke.

  1 year post index procedure

Secondary Outcomes (33)

• Number of Participants With Procedural Success

  Procedure

• Evaluation of Adverse Event Rates (Descriptive Endpoint)

  30 days post index procedure

• Evaluation of Adverse Event Rates (Descriptive Endpoint)

  1 year post index procedure

• Evaluation of Adverse Event Rates (Descriptive Endpoint)

  2 years post index procedure

• Evaluation of Adverse Event Rates (Descriptive Endpoint)

  3 years post index procedure

Study Arms (2)

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).

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.

Device: Transcatheter Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Replacement DEVICE

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

Exploratory Registry Arm; Primary Analysis Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital

Adelaide, Australia

Location

GenesisCare - Wesley Hospital

Auchenflower, QLD 4066, Australia

Location

Rigshospitalet

Copenhagen, Denmark

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

Location

Universitätsklinikum Rostock (AöR)

Rostock, Germany

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Morriston Hospital - ABM University Health Board

Morriston, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: Karine Miquel
• Organization: Abbott

karine.miquel@abbott.com

+32 479 600 107

Study Officials

• Barathi Sethuraman

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 12, 2021
• Study Start: October 21, 2021
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GB (2); DE (2); DK (1)