Portico Next Generation Approval Study

NCT ID: NCT04011722

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (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 (Conformité Européenne) Mark and FDA approval.

Detailed Description

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

Up to 399 (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 Navitor Transcatheter Aortic Heart Valve implantation will undergo Navitor 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.

This study will also include a product size extension, Navitor Titan™ valve, which includes up to 90 subjects (Titan cohort) who will undergo an implant attempt with the Navitor Titan valve. Subjects enrolled in the Titan cohort will undergo the same screening, baseline, procedure and follow-up assessments as the Portico NG cohort.

Conditions

Symptomatic Severe Aortic Stenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Portico™ NG (Navitor) valve, FlexNav™ Delivery System

Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).

Group Type: EXPERIMENTAL

Portico™ NG (Navitor) Valve and FlexNav™ Delivery System

Intervention Type: DEVICE

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.

Navitor Titan Valve

Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.

Group Type: EXPERIMENTAL

Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System

Intervention Type: DEVICE

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.

Interventions

Portico™ NG (Navitor) Valve and FlexNav™ Delivery System

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.

Intervention Type: DEVICE

Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System

Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.

3. 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).

4. Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)

Exclusion Criteria

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. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.

3. 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

4. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation

5. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).

6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).

7. 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.

8. Minimum access vessel diameter of <5.0mm for small FlexNav™ Delivery System and <5.5 mm for large FlexNav™ Delivery System

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Via Christi Regional Medical Center

Wichita, Kansas, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Atlantic Health System - Morristown Memorial Hospital

Morristown, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Montefiore Medical Center - Moses Division

New York, New York, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

The Methodist Hospital

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Intermountain St. George Regional Hospital

St. George, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

St. Andrew's Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Rigshospitalet

Copenhagen, , Denmark

Policlinico San Donato

San Donato Milanese, Lombard, Italy

Royal Victoria Hospital

Belfast, Northern Ireland, United Kingdom

Morriston Hospital - ABM University Health Board

Morriston, Swansea, United Kingdom

Countries

United States; Australia; Denmark; Italy; United Kingdom

References

Reardon MJ, Chehab B, Smith D, Walton AS, Worthley SG, Manoharan G, Sultan I, Yong G, Harrington K, Mahoney P, Kleiman N, Makkar RR, Fontana G, DeLago A, Ramana RK, Bates N, Sondergaard L. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. JACC Cardiovasc Interv. 2023 Mar 27;16(6):681-689. doi: 10.1016/j.jcin.2023.02.002. Epub 2023 Feb 27.

Reference Type: DERIVED

PMID: 36990558 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10308

Identifier Type: OTHER

Identifier Source: secondary_id

ABT-CIP-10297

Identifier Type: -

Identifier Source: org_study_id