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Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO IDE)

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ClinicalTrials.gov Identifier: NCT02000115
Recruitment Status : Recruiting
First Posted : December 3, 2013
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

November 26, 2013
December 3, 2013
October 15, 2018
May 2014
October 2018   (Final data collection date for primary outcome measure)
  • Primary Effectiveness Endpoint [ Time Frame: One year ]
    A composite of all-cause mortality or disabling stroke at one year.
  • Primary Safety Endpoint [ Time Frame: 30 days ]
    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.
The composite endpoint of all cause mortality or disabling stroke at one year. [ Time Frame: One year ]
Primary Endpoint for High and Extreme Risk Cohorts: The composite endpoint of all cause mortality or disabling stroke at one year.
Complete list of historical versions of study NCT02000115 on ClinicalTrials.gov Archive Site
  • Severe aortic regurgitation [ Time Frame: One year ]
    Severe aortic regurgitation (AR) at one year
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One year ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year
  • Moderate or severe aortic regurgitation [ Time Frame: One year ]
    Moderate or severe aortic regurgitation at one year
  • Six minute walk [ Time Frame: One year ]
    Six minute walk at one year
Not Provided
Not Provided
Not Provided
 
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Valve Stenosis
  • Device: Portico transcatheter aortic valve
    St. Jude Medical transcatheter Portico aortic valve
  • Device: Commercially available transcatheter aortic valve
    Commercially available transcatheter aortic valve
  • Experimental: Randomized IDE Cohort, Portico Valve

    Portico transcatheter aortic valve.

    Status: ACTIVE, NOT ENROLLING.

    Intervention: Device: Portico transcatheter aortic valve
  • Active Comparator: Randomized IDE Cohort, CAV

    Commercially available transcatheter aortic valve (CAV).

    Status: ACTIVE, NOT ENROLLING.

    Intervention: Device: Commercially available transcatheter aortic valve
  • Experimental: 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.

    Intervention: Device: Portico transcatheter aortic valve
  • Experimental: 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: RECRUITING.

    Intervention: Device: Portico transcatheter aortic valve
  • 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.

    Intervention: Device: Portico transcatheter aortic valve
  • 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: RECRUITING.

    Intervention: Device: Portico transcatheter aortic valve
Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Søndergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
758
1610
June 2024
October 2018   (Final data collection date for primary outcome measure)

Inclusion:

High Risk Cohort:

All candidates for the High Risk Cohort of this study must meet all the following 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.

Extreme Risk Cohort:

All candidates for the Extreme Risk Cohort of this study must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and 1. 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:

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.

Exclusion Criteria:

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).
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact: Angie Roach aroach@sjm.com
Australia,   United States
 
 
NCT02000115
1203
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center
Principal Investigator: Gregory Fontana, MD Los Robles Regional Medical Center
St. Jude Medical
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP