Portico NG Approval Study

  • STATUS
    Recruiting
  • End date
    Jul 17, 2026
  • participants needed
    189
  • sponsor
    Abbott Medical Devices
Updated on 17 March 2021
Investigator
Mira Tissari
Primary Contact
Mission Health & Hospitals (6.2 mi away) Contact
+20 other location

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 moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformit Europenne) Mark and FDA approval.

Description

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

Up to 189 (includes up to 20 roll-ins) 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.

Details
Condition Symptomatic Severe Aortic Stenosis
Treatment Portico™ NG Valve and FlexNav™ Delivery System
Clinical Study IdentifierNCT04011722
SponsorAbbott Medical Devices
Last Modified on17 March 2021

Eligibility

Yes No Not Sure

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/mm). 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note