Symptomatic Severe Aortic StenosisNCT04011722
Portico Next Generation Approval Study
A study testing Portico™ NG (Navitor) Valve and FlexNav™ Delivery System and Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 28 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System and Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 17 Sep 2019to Jan 2033
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)
Who cannot join
- 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
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States21 sites
Albany Medical Center
Albany, New York, 12208
Mission Health & Hospitals
Asheville, North Carolina, 28801
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Methodist Hospital
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46240
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, 07962
Columbia University Medical Center/NYPH
New York, New York, 10032
Montefiore Medical Center - Moses Division
New York, New York, 10467
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Intermountain St. George Regional Hospital
St. George, Utah, 84790
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Via Christi Regional Medical Center
Wichita, Kansas, 67214
Australia3 sites
St. Andrew's Hospital
Adelaide, South Australia, 5000
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
United Kingdom2 sites
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
Morriston Hospital - ABM University Health Board
Morriston, SWANSEA, SA6 6NL
About this study
Official title: Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
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.
Read the 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 through 10 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
- Being tested
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Heart Valve Disease, High Surgical Risk, Portico NG (Navitor) Valve, Extreme Surgical Risk, Navitor Titan Valve
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portico™ NG (Navitor) Valve and FlexNav™ Delivery SystemDevice
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 (35mm) Valve and Large FlexNav™ Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Portico™ NG (Navitor) valve, FlexNav™ Delivery System | Experimental | 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). Receives: Device: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System |
| Navitor Titan Valve | Experimental | Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+. Receives: Device: Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint is All-cause Mortality
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Measured: at 30 days
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Number of participants with moderate or greater paravalvular leak at 30 days.
Measured: at 30 days
Secondary outcomes (1)
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
The secondary endpoint is defined as a non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications at 30 days.
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start17 Sep 2019
- Primary completion12 Jan 2023
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Devices under investigation in this clinical study include the Portico™ (Navitor) Valve (23mm, 25mm, 27mm and 29mm sizes), Navitor Titan Valve (35 mm), FlexNav™ Delivery System (small and large) and Portico™ NG (Navitor) Loading System(s) (small and large), and Navitor Loading System - LG+, all of which are currently approved for investigational use only.
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011722
- Sponsor's protocol ID
- ABT-CIP-10297
- Other IDs
- ABT-CIP-10308
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2019
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36990558
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04011722
- Acronym / sponsor ID
- ABT-CIP-10297
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Heart Valve Disease, High Surgical Risk, Portico NG (Navitor) Valve, Extreme Surgical Risk, Navitor Titan Valve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- Jan 2033 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 1 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 through 10 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Devices under investigation in this clinical study include the Portico™ (Navitor) Valve (23mm, 25mm, 27mm and 29mm sizes), Navitor Titan Valve (35 mm), FlexNav™ Delivery System (small and large) and Portico™ NG (Navitor) Loading System(s) (small and large), and Navitor Loading System - LG+, all of which are currently approved for investigational use only.
| Arm | Type | Receives |
|---|---|---|
| Portico™ NG (Navitor) valve, FlexNav™ Delivery System | Experimental | Device: Portico™ NG (Navitor) Valve and FlexNav™ Delivery SystemPortico ™ 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). |
| Navitor Titan Valve | Experimental | Device: Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery SystemNavitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portico™ NG (Navitor) Valve and FlexNav™ Delivery SystemSubjects 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. | Device | Portico™ NG (Navitor) valve, FlexNav™ Delivery System |
| Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery SystemSubjects 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. | Device | Navitor Titan Valve |
Primary outcome
Primary Safety Endpoint is All-cause Mortality
Time frame: at 30 days
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Time frame: at 30 days
Number of participants with moderate or greater paravalvular leak at 30 days.
1 secondary outcome
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Time frame: at 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36990558Reardon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portico™ NG (Navitor) Valve and FlexNav™ Delivery System and Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Australia, United Kingdom, Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint is All-cause Mortality (time frame: at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.