Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Aortic Valve Stenosis Clinical Trial

— PORTICO-IDE  

Official title:

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02000115
• Other study ID #: 1203
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: Kimberly S Behning
• Phone: 651-756-5622
• Email: kimberly.behning[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.

Description:

The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up to 70 investigational sites in the United States and Australia. Patients will be randomized (1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR) System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary safety endpoint) and 1 year (primary effectiveness endpoint). At the time of the primary randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted on the intention-to-treat (n=750) population.

The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE trial and will include up to 200 high or extreme risk subjects; including a minimum of 100 analysis subjects. The study will characterize the safety of the next-generation Portico Delivery System ("FlexNav™ Delivery System"). The primary analysis cohort will include FlexNav analysis subjects.

The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart Valve.

All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 12-months and then annually through 5-years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: July 2025
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria

1. Subjects must have co-morbidities such that the surgeon and cardiologist Co-Investigators concur that the predicted risk of operative mortality is =15% or a minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet the STS score criteria of = 8% can be included in the study if a peer review by at least two surgeons concludes and documents that the patient's predicted risk of operative mortality is =15%. The surgeon's assessment of operative comorbidities not captured by the STS score must be documented in the study case report form as well as in the patient medical record.

2. Subject is 21 years of age or older at the time of consent.

3. Subject has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of = 1.0 cm2 (indexed effective orifice area (EOA) = 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).

4. Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association (NYHA) Functional Classification of II, III, or IV.

5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

6. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

7. Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography (CT) conducted within 12 months prior to informed consent. Note: if CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject selection committee.

For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and

8. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.

Exclusion Criteria

1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.

2. Aortic valve is a congenital unicuspid or congenital bicuspid valve or is non-calcified as verified by echocardiography.

3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).

4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.

5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects with pre-existing surgical bioprosthetic aortic heart valve should be considered for the Valve-in-Valve registry.

6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³).

7. History of bleeding diathesis or coagulopathy.

8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.

9. Untreated clinically significant coronary artery disease requiring revascularization.

10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.

11. Need for emergency surgery for any reason.

12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).

13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.

14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to index procedure.

16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.

17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).

18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.

19. Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.

20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).

21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.

22. Aortic root angulation > 70° (applicable for transfemoral patients only).

23. Currently participating in an investigational drug or device study.

24. Active bacterial endocarditis within 6 months prior to the index procedure.

25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.

26. Non-calcified aortic annulus

27. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath such as severe obstructive calcification, or severe tortuosity (applicable for transfemoral patients only).

Additional Exclusion Criteria (Transcatheter Access Related)

For selection of an appropriate alternative access delivery method, subjects were screened using the following access specific exclusion criteria:

Transaortic (TAo) Subject Cohort Specific Exclusion Criteria

1. Subject has pre-existing patent RIMA graft that would preclude access.

2. Subject has a hostile chest or other condition that complicates transaortic access.

3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access.

Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:

1. Subject has a distance between the annular plane and the aortic access site <7 cm (2.8")

2. Subject has a distance between the annular plane and the separate introducer sheath distal tip <6 cm (2.4")

Subclavian/Axillary Subject Cohort Specific Exclusion Criteria

1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the applicable 18 Fr or 19 Fr delivery system.

2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.

3. Subject's aortic root angulation is:

• Left Subclavian/Left Axillary: >70?

• Right Subclavian/Right Axillary: >30?

4. Subject has a history of patent LIMA/RIMA graft that would preclude access

Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery System:

1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane and the integrated sheath distal tip <17 cm (6.7")

2. Subject's access vessel requires the delivery system to be advanced through a separate introducer sheath

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Portico transcatheter aortic valve
St. Jude Medical transcatheter Portico aortic valve
• Commercially available transcatheter aortic valve
Commercially available transcatheter aortic valve

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Macquarie University Hospital	Sydney	New South Wales
United States	Albany Medical Center	Albany	New York
United States	Mission Health and Hospitals	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Heart Hospital of Austin	Austin	Texas
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Morton Plant Valve Clinic	Clearwater	Florida
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	John Muir Medical Center	Concord	California
United States	Delray Medical Center	Delray Beach	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CHI St. Luke's Health Baylor College of Medicine Medical Center	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Winthrop University Hospital	Mineola	New York
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Centennial Medical Center	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian Hospital / Cornell University	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Florida Hospital Orlando	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Huntington Memorial Hospital	Pasadena	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Francis Hospital	Roslyn	New York
United States	Mercy General Hospital	Sacramento	California
United States	Sutter Memorial Hospital	Sacramento	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Main Line Health Center/Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint (Randomized IDE Cohort)	A composite of all-cause mortality or disabling stroke at one year.	One-year from randomization
Primary	Primary Safety Endpoint (Randomized IDE Cohort)	Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days.	30 days from randomization
Primary	Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)	Valve Academic Research Consortium (VARC) 2- defined major vascular complications	30 days from index procedure
Secondary	Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)	Severe aortic regurgitation (AR) at one year	One year
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)	Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Scale 0 to 100; with higher scores indicating better symptoms and physical functioning	One year
Secondary	Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)	Moderate or severe aortic regurgitation at one year	One year
Secondary	Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)	Six-minute walk distance at one year	One year
Secondary	Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)	Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days from index procedure.; Anticipated completion date (2022)	30 days from index procedure
Secondary	Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)	A composite of all-cause mortality or disabling stroke at one year Anticipated completion data (2023)	One year from index procedure