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Portico NG Approval Study

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ClinicalTrials.gov Identifier: NCT04011722
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Portico™ NG Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of freedom from moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Stenosis Device: Portico™ NG Valve and FlexNav™ Delivery System Not Applicable

Detailed Description:

The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study.

Up to 140 high or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico NG Transcatheter Aortic Heart Valve implantation will undergo Portico™ NG Valve implantation via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure.

Subjects participating in the clinical study will be followed for a total of 12 months with data collected at screening, baseline, procedure, prior to hospital discharge, and follow-up at 30 days, 12 months and annually at 2, 3, 4 and 5 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Devices under investigation in this clinical study include the Portico™ NG Valve (23mm, 25mm, 27mm and 29mm sizes), FlexNav™ Delivery System(s) (small and large) and Portico™ NG Loading System(s) (small and large), all of which are currently approved for investigational use only.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Portico™ NG valve, FlexNav™ Delivery System
Portico valve implantation with the new generation Portico NG valve (23mm, 25mm, 27mm and 29mm sizes), second-generation FlexNav Delivery system (small and large) and Portico™ NG Loading System(s) (small and large)
Device: Portico™ NG Valve and FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the new generation Portico NG valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.




Primary Outcome Measures :
  1. Primary safety endpoint is all-cause mortality [ Time Frame: at 30 days ]
  2. Primary effectiveness endpoint is freedom from moderate or greater paravalvular leak [ Time Frame: at 30 days ]

Secondary Outcome Measures :
  1. Secondary endpoint is freedom from mild or greater paravalvular leak [ Time Frame: at 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
  • Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
  • Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
  • Aortic annulus diameter of 19-27mm and ascending aorta diameter of 26-42 mm for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography) conducted within 12 months prior to informed consent. (If a CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D echocardiogram and non-contrast CT of chest and abdomen/pelvis may be accepted).

Exclusion Criteria:

  • Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
  • Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³). History of bleeding diathesis or coagulopathy
  • Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
  • Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
  • 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 or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
  • Minimum access vessel diameter of <5.0mm for small FlexNav™ Delivery System and <5.5 mm for large FlexNav™ Delivery System

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011722


Contacts
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Contact: Mira Tissari +32 470 47 0942 mira.tissari@abbott.com
Contact: Mary-Margaret Seale +1 612 513 0822 mary.seale@abbott.com

Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04011722     History of Changes
Other Study ID Numbers: ABT-CIP-10297
ABT-CIP-10308 ( Other Identifier: Abbott )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Abbott Medical Devices:
Aortic Stenosis
Transcatheter Aortic Valve Replacement
Heart Valve Disease
High surgical risk
Portico NG

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction