Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The PORTICO IDE clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.
- Aortic Valve Stenosis
- Eligible Ages
- Over 21 Years
- Eligible Genders
- Accepts Healthy Volunteers
for the TAVR Leaflet Motion Sub-study, until the minimum sub-study sample size has been achieved:
1. Be willing and able to undergo, at both 30-days and 6-months post-implant, a Multi-Slice Computed Tomography (MSCT) scan (or TEE, if medically or technically contraindicated for an MSCT) of the heart and cardiac structures.
High and Extreme Risk Cohort:
Candidates will be excluded from the study if any of the following conditions are present:
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 mg/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).
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Randomized IDE Cohort, Portico Valve
|Portico transcatheter aortic valve. Status: ACTIVE, NOT ENROLLING.||
Randomized IDE Cohort, CAV
|Commercially available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.||
Portico Continued Access Protocol (CAP)
|The PORTICO IDE CAP is a prospective, multicenter, single-arm, continued access arm designed to collect additional safety and clinical effectiveness data on the Portico Transcatheter Heart Valve and Delivery System (Portico) upon completion of enrollment in the pivotal cohort and while the pre-market approval (PMA) application for the Portico Transcatheter Heart Valve and the Portico Delivery System is under FDA review. Status: RECRUITING.||
Nested Roll-in Registry
|Prior to enrolling subjects in the pivotal IDE randomized cohort, sites will be required to complete a minimum of two (2) and up to three (3) roll-in patients per primary implanting physician. The roll-in registry data will be analyzed and presented separately. Status: ACTIVE, NOT ENROLLING.||
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.||
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: RECRUITING.||
- Abbott Medical Devices
Study ContactJami Maccombs
The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70 investigational sites. The study is powered to analyze the high risk cohort and extreme risk cohort together against a commercially available control for the primary safety and effectiveness endpoints. In addition, data for each cohort will be analyzed separately in a subgroup analysis.
A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician will be allowed. These roll-in subjects will be added to a Roll-in Registry. In addition, up to 100 subjects may be enrolled in a Valve-in-Valve registry. Implanting physicians with prior Portico experience and with a minimum of 3 implants in the last 6 months will not be required to include roll-in patients.
Registry data will not be included in the randomized cohort analysis, but will be analyzed and presented separately.
The FlexNav study will be conducted as a separate arm of the PORTICO IDE trial and will include 100 high or extreme risk patients. Safety data for the FlexNav™ Delivery System will be summarized and descriptively compared to the first-generation Portico Delivery System.
Following completion of enrollment in the randomized cohort, subjects will be eligible for enrollment in the Portico IDE Continued Access Protocol (CAP) Study.
The sponsor will submit a final clinical report for combined risk cohorts as enrollment and follow-up is completed according to the protocol.