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Portico Next Generation Approval Study

StatusActive, Not Recruiting
PhaseNot applicable
Started2019-09-17
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
Study Status, Study Description v31
Completion pushed: 2027-12 → 2033-01
Study description-6 characters
[...] discharge, and follow-up at 30 days, 12 months and annually atthrough 2, 3, 4 and 510 years. This study will also include a product size extensio [...]
2026-06-05
Study Status, Contacts/Locations v30
Study sitesdetails revised at 1 of 28 sites
2025-07-29
Study Status v29
Re-verified, no change to tracked fields
2025-01-23
Study Status, Contacts/Locations v28
Study sites29→28
2024-06-27
Study Status, Baseline Characteristics v27
Results first postednot stated→2024-07-01
Show 26 earlier versions
2024-06-02
Study Status, Baseline Characteristics, Adverse Events v26
Re-verified, no change to tracked fields
2024-04-29
Study Identification, Study Status, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v25
Secondary endpoints1 entry, revised
Non-hierarchical compositeComposite of allAll-cause mortalityMortality, disablingDisabling strokeStroke, lifeLife threateningThreatening bleedingBleeding, acuteAcute kidneyKidney injuryInjury (stageStage 3), or majorMajor vascularVascular complicationsComplications
Primary endpoints2 entries, revised
Primary effectivenessEffectiveness endpointEndpoint is moderateModerate or greaterGreater paravalvularParavalvular leakLeak Primary safetySafety endpointEndpoint is allAll-cause mortalityMortality
Study title+13 characters
Portico NGNext Generation Approval Study
2024-02-16
2 amendments v23-v24
2 re-verifications since 2023-10-16, no change to tracked fields
2023-04-04
Study Status v22
Primary completion dateestimated 2023-01→confirmed 2023-01-12
2022-12-15
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-11→2023-01
Completion date2027-10→2027-12
Enrollment targetestimated 399→confirmed 333
Study sites30→29
2022-10-18
Study Status, Contacts/Locations v20
Re-verified, no change to tracked fields
2022-10-04
Study Status v19
Primary completion date2022-09→2022-11
2022-08-16
Study Status, Contacts/Locations v18
Study sitesdetails revised at 2 of 30 sites
2022-07-11
Study Status, Contacts/Locations v17
Study sites30 entries, revised
Intermountain HealthcareSt. DixieGeorge Regional Hospital
2022-06-01
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 30 sites
2022-05-03
Study Status, Contacts/Locations v15
Study sites25→30
2022-04-06
Study Status, Contacts/Locations v14
Study sitesdetails revised at 4 of 25 sites
2022-03-03
Study Status, Contacts/Locations v13
Study sitesdetails revised at 6 of 25 sites
2022-02-17
Study Status, Contacts/Locations v12
Study sitesdetails revised at 7 of 25 sites
2021-11-16
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v11
Primary completion date2021-06→2022-09
Completion date2026-07→2027-10
Enrollment target189→399
Study sites22→25
Study arms1→2
InterventionsPortico™ NG Valve and FlexNav™ Delivery System (Device)→Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System (Device), Portico™ NG (Navitor) Valve and FlexNav™ Delivery System…
Eligibility criteria-229 characters
Key Inclusion Criteria: Subjects must have a Society of Thoracic [...] s prior to informed consent). Aortic annulus diameter of 19-27mm30mm 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) Key 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 infarcti [...]
Study description+327 characters
[...] ter, international, single-arm investigational study. Up to 189399 (includes up to 20 roll-ins) high or extreme risk patients [...] ubject selection committee to meet eligibility criteria for Portico NGNavitor Transcatheter Aortic Heart Valve implantation will undergo Portico™ NGNavitor Valve implantation via a transfemoral or alternative access [...] p 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. Subject [...]
2021-03-11
Study Status, Contacts/Locations v10
Primary completion date2021-04→2021-06
Completion date2026-06→2026-07
Study sitesdetails revised at 1 of 22 sites
2020-10-08
Study Status, Contacts/Locations v9
Study sites20→22
2020-06-24
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 20 sites
2020-05-26
Study Status, Contacts/Locations v7
Study sitesdetails revised at 6 of 20 sites
2020-04-07
Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v6
Primary completion date2020-11→2021-04
Completion date2026-02→2026-06
Start date2019-08-29→2019-09-17
Enrollment target140→189
Secondary endpoints1 entry, revised
SecondaryNon-hierarchical endpointcomposite isof freedomall-cause frommortality, milddisabling stroke, life threatening bleeding, acute kidney injury (stage 3), or greatermajor paravalvularvascular leakcomplications
Primary endpoints2 entries, revised
Primary effectiveness endpoint is freedom from moderate or greater paravalvular leak
Study description+29 characters
[...] ter, international, single-arm investigational study. Up to 140189 (includes up to 20 roll-ins) high or extreme risk patients with symptomatic, severe nati [...]
Study sitesdetails revised at 8 of 20 sites
2019-11-25
Study Status, Contacts/Locations v5
Study sites19→20
2019-10-18
Study Status, Contacts/Locations v4
Study sites18→19
2019-09-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-10-31→confirmed 2019-08-29
Study sites0→18
2019-08-06
Study Status, Study Description v2
Completion date2022-02→2026-02
Study description+33 characters
[...] edure, prior to hospital discharge, and follow-up at 30 days and, 12 months and annually at 2, 3, 4 and 5 years.
2019-07-06
Study Identification, Study Status, Study Description, Eligibility v1
Eligibility criteria+99 characters
[...] ect has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV. Subject has sen [...] ned 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 veloci [...] r 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 [...]
Study description+41 characters
[...] proach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure. Subjects participating in the clinical study will [...]
2019-07-04
Original filing
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.
Trial Details
NCT Number NCT04011722
Lead Sponsor Abbott Medical Devices
Conditions Symptomatic Severe Aortic Stenosis
Enrollment 333 participants
Start Date 2019-09-17
Primary Completion 2023-01-12 (estimated)
Study Completion 2033-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-21