Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Brief SummaryThe 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.
Detailed DescriptionThe 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.
Inclusion and Exclusion Criteria
- Inclusion: High Risk Cohort: All candidates for the High Risk Cohort of this study must meet all the following inclusion criteria:
- 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.
- Subject is 21 years of age or older at the time of consent.
- 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).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
- 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.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- 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. Extreme Risk Cohort: All candidates for the Extreme Risk Cohort of this study must meet # 2, 3, 4, 5, 6, 7 of
- 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. All Candidates: Additionally, all candidates for the study must meet the following inclusion criteria for the TAVR Leaflet Motion Sub-study, until the minimum sub-study sample size has been achieved:
- 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. Exclusion Criteria: High and Extreme Risk Cohort: Candidates will be excluded from the study if any of the following conditions are present:
- Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified as verified by echocardiography.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
- 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.
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm³).
- History of bleeding diathesis or coagulopathy.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Need for emergency surgery for any reason.
- Hypertrophic cardiomyopathy with or without obstruction (HOCM).
- Severe ventricular dysfunction with LVEF <20% as measured by resting echocardiogram.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.
- Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
- 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).
- Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
- Aortic root angulation > 70° (applicable for transfemoral patients only).
- Currently participating in an investigational drug or device study.
- Active bacterial endocarditis within 6 months prior to the index procedure.
- Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
- Non-calcified aortic annulus
- 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).
Please contact Jose Escobar to learn more about where you can participate in this trial. Please use the contact form on the right side.