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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02000115




Registration number
NCT02000115
Ethics application status
Date submitted
26/11/2013
Date registered
3/12/2013
Date last updated
17/08/2020

Titles & IDs
Public title
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Scientific title
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Secondary ID [1] 0 0
1203
Universal Trial Number (UTN)
Trial acronym
PORTICO-IDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Portico transcatheter aortic valve
Treatment: Devices - Commercially available transcatheter aortic valve

Experimental: Randomized IDE Cohort, Portico Valve - Portico transcatheter aortic valve.
Status: ACTIVE, NOT ENROLLING.

Active Comparator: Randomized IDE Cohort, CAV - Commercially available transcatheter aortic valve (CAV).
Status: ACTIVE, NOT ENROLLING.

Experimental: Nested Valve-in-valve Registry - Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve into the existing bioprosthesis will be considered for eligibility in the Valve-in-Valve registry. The Valve-in-Valve registry will enroll up to 100 qualified subjects from the pivotal IDE trial or CAP. Data from the valve-in-valve registry will be analyzed and presented separately to support an expanded indication for Valve-in-Valve use (Portico-in-SAVR).
Status: RECRUITING.

Experimental: FlexNav Delivery System Study - The primary objective of the PORTICO IDE FlexNav study is to characterize the safety of the next-generation FlexNav Delivery System. The FlexNav study will be conducted as a prospective, multicenter, open-label study arm of the PORTICO IDE trial and will include 100 high or extreme risk patients with symptomatic, severe native aortic stenosis who meet eligibility criteria for the PORTICO IDE trial via a transfemoral or alternative access approach.
Status: ACTIVE, NOT ENROLLING


Treatment: Devices: Portico transcatheter aortic valve
St. Jude Medical transcatheter Portico aortic valve

Treatment: Devices: Commercially available transcatheter aortic valve
Commercially available transcatheter aortic valve

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint - A composite of all-cause mortality or disabling stroke at one year.
Timepoint [1] 0 0
One year
Primary outcome [2] 0 0
Primary Safety Endpoint - 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.
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Severe aortic regurgitation - Severe aortic regurgitation (AR) at one year
Timepoint [1] 0 0
One year
Secondary outcome [2] 0 0
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year
Timepoint [2] 0 0
One year
Secondary outcome [3] 0 0
Moderate or severe aortic regurgitation - Moderate or severe aortic regurgitation at one year
Timepoint [3] 0 0
One year
Secondary outcome [4] 0 0
Six minute walk - Six minute walk at one year
Timepoint [4] 0 0
One year

Eligibility
Key inclusion criteria
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 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 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 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 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.
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 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 LVEF <20% as measured by resting echocardiogram.

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

15. Active peptic ulcer or upper 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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the PORTICO pivotal IDE trial was to evaluate the safety and effectiveness
of the 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.
Trial website
https://clinicaltrials.gov/show/NCT02000115
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raj Makkar, MD
Address 0 0
Cedars-Sinai Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications