Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System (Portico TA EU)

February 1, 2019 updated by: Abbott Medical Devices
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study.
  2. Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
  3. Subject's aortic annulus is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure.
  4. Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure).
  5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
  6. Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee.
  7. Subject's predicted operative mortality or serious, irreversible morbidity risk is less than (<) 50% at 30 days post index procedure.

Exclusion Criteria:

  1. Subject is unwilling or unable to comply with all study-required follow-up evaluations.
  2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
  3. Subject has a chest condition than prevents transapical access.
  4. Subject has carotid artery disease requiring intervention.
  5. Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
  6. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
  7. Subject has mitral valvular regurgitation greater than (>) grade III.
  8. Subject has moderate or severe mitral stenosis.
  9. Subject has aortic root angulation greater than (>) 70 degrees (horizontal aorta).
  10. The distance from the left ventricular apex to the aortic annulus is less than (<) 45mm (4.5cm).
  11. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
  12. Subject refuses any blood product transfusion.
  13. Subject refuses surgical valve replacement.
  14. Subject has left ventricular ejection fraction (LVEF) less than (<) 20%.
  15. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
  16. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to (≤) 14 days of index procedure.
  17. Subject has severe basal septal hypertrophy that would interfere with transcatheter valve placement.
  18. Subject has a history of, or is currently diagnosed with endocarditis.
  19. Subject has imaging evidence of intracardiac mass, thrombus, or vegetation.
  20. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
  21. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
  22. Subject with significant pulmonary disease as determined and documented by the Investigator.
  23. Subject has significant chronic steroid use as determined and documented by the Investigator.
  24. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
  25. Subject has renal insufficiency as evidenced by a serum creatinine greater than (>) 3.0 mg/dL (265.5µmol/L) or end-stage renal disease requiring chronic dialysis.
  26. Subject has morbid obesity defined as a BMI greater than or equal to (≥) 40.
  27. Subject has ongoing infection or sepsis.
  28. Subject has blood dyscrasias (e.g., leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
  29. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or the Subject Selection Committee, precludes the subject from study participation.
  30. Significant ascending aortic disease documented by diameter greater than 40mm.
  31. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
  32. Subject is currently participating in another investigational drug or device study.
  33. Subject requires emergency surgery for any reason.
  34. Subject has a life expectancy less than (<) 12 months.
  35. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
  36. Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
  37. Subject has a documented allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Portico Implant
Device: Portico Transapical Aortic Valve System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All cause mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event rates
Time Frame: 30 days
  • Cardiovascular mortality
  • Myocardial Infarction (MI)
  • Major Stroke
  • Minor Stroke
  • Acute Kidney Injury (AKI)
  • Vascular access site and Access-related complications
  • Bleeding
  • Composite of periprocedural encephalopathy, all stroke, and all TIA
30 days
Functional improvements from baseline
Time Frame: 30 days
  • NYHA Functional Classification
  • Six Minute Walk Test
  • Effective Orifice Area (EOA)
30 days
Acute device success
Time Frame: At time of procedure
  • Successful apical access, delivery and deployment of the device and successful retrieval of the delivery system,
  • Correct position of the device in the proper anatomical location,
  • Intended performance of the prosthetic heart valve (Aortic Valve Area greater than (>)1.0 cm2 and mean aortic valve gradient less than (<) 20 mmHg or peak velocity less than (<) 3 m/s, without moderate or severe prosthetic valve AR), and
  • Only one valve implanted in the proper anatomical location
At time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Walther, MD, PhD, Kerckhoff Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1106

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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