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Portico Resheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO)

Description

Rationale: To potentially offer a SJM transcatheter Portico valve that is safe and effective for subjects with symptomatic severe aortic valve stenosis who are considered at high or extreme risk for conventional surgical aortic valve replacement. Purpose: The Portico Transcatheter Heart Valve is indicated for patients with symptomatic severe native aortic stenosis, who are considered high surgical or extreme surgical risk. Study population: High-Risk:Subjects must have comorbidities such that the surgeon and cardiologist CoPIs concur that the predicted risk of operative mortality is 15% and/or a minimum STS score of 8, and has symptomatic aortic stenosis. Extreme Risk: 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, and has symptomatic aortic stenosis. Specifically the predicted risk of operative mortality should exceed 50%. Study Methodology: The PORTICO clinical trial is a prospective, multicenter, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via the transfemoral and alternative delivery methods, in high and extreme risk cohorts. If the participant takes part in the study, their treatment will be determined in a way similar to flipping a coin, called randomization. Prior to randomization, patients will be classified as high or extreme risk and stratified by vascular access within each risk group. Depending on their valve size they will be randomized into one of two study groups which will determine the device they are implanted with: Test Group: Portico Transcatheter Heart Valve / Control Group: FDAapproved Transcatheter Valve. There are also 2 registries in this study and they may be placed in a registry which will not require randomization. All registry patients will receive a TAVI and will have follow up as a research participant. The first registry is called a rollin registry. They may be considered for this registry based on their order of enrollment in the study. If they are one of the first three patients to enroll in the trial they will not be randomized but will receive a Portico valve. The second registry is for patients who already have a prosthetic aortic valve in place and are in need of replacing the prosthetic valve. If they qualify for this registry, a Portico valve will be implanted inside their existing prosthetic valve. The PORTICO trial will include a maximum of 908 subjects at up to 70 investigational sites. Study endpoints: A non-hierarchical composite of all-cause mortality, disabling stroke, or moderate or greater aortic insufficiency/regurgitation at one year for high and extreme risk cohort. Follow-up: 30 day, 6 month, One year and annually thereafter through year 5. Statistics: Basic descriptive statistics and P values will be reported.Analysis: The primary analysis will be based on the intent to treat (ITT) population. The ITT population is defined at the time that randomization treatment is assigned to the subject. For the primary analysis in this study, subjects will be analyzed according to their ITT arm, and the randomization day will be considered Day 0 when referring to a specific number of days.

Phase

N/A

Inclusion and Exclusion 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.

  • 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).

Sites

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