Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT02000115
• Date of registration: 26/11/2013
• Prospective Registration: Yes
• Primary sponsor: Abbott Medical Devices
• Public title: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial PORTICO-IDE
• Scientific title: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
• Date of first enrolment: May 2014
• Target sample size: 1150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02000115
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Australia, United States

Contacts

• Name: Kimberly S Behning

• Name: Raj R Makkar, MD
• Affiliation: Cedars-Sinai Medical Center

• Name: Gregory P Fontana, MD
• Affiliation: Los Robles Regional Medical Center

Key inclusion & exclusion 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 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


Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Intervention(s)

Device: Commercially available transcatheter aortic valve

Device: Portico transcatheter aortic valve

Primary Outcome(s)

Primary Effectiveness Endpoint (Randomized IDE Cohort) [Time Frame: One-year from randomization]

Primary Safety Endpoint (Randomized IDE Cohort) [Time Frame: 30 days from randomization]

Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study) [Time Frame: 30 days from index procedure]

Secondary Outcome(s)

Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort) [Time Frame: One year]

Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort) [Time Frame: One year]

Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort) [Time Frame: One year]

Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry) [Time Frame: One year from index procedure]

Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry) [Time Frame: 30 days from index procedure]

Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort) [Time Frame: One year]

Secondary ID(s)

1203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/01/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02000115