Trials Sponsors Conditions Drugs Pricing

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

NAVITOR Heart diseaseTranscatheter aortic valve implantation (TAVI)Aortic stenosis Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
at 30 Days
Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability
The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.
at 12 months

Secondary Outcomes (3)

Mean Change in Mean Transvalvular Gradient
Baseline to 12 months
Mean Change in Effective Orifice Area (EOA)
Baseline to12 months
Mean Change In KCCQ Quality Of Life Score
Baseline to 12 months

Study Arms (1)

Primary Analysis Cohort

EXPERIMENTAL

Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)

Device: Navitor Transcatheter Aortic valve and FlexNav Delivery system

Interventions

Navitor Transcatheter Aortic valve and FlexNav Delivery systemDevice

Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system.

Primary Analysis Cohort

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at intermediate or low risk for open surgical aortic valve replacement (i.e., heart team estimates risk of surgical mortality \< 7% at 30 days, considering the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator). \*

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (37)

Fiona Stanley Hospital

Murdoch, Murdoch, WA 6150, Australia

Prince of Wales Hospital

Sydney, Sydney, NSW 2031, Australia

Princess Alexandra Hospital

Woolloongabba, Woolloongabba, QLD 4102,, Australia

St. Andrew's Hospital

Adelaide, Australia

The Alfred Hospital

Melbourne, Australia

Macquirie University Hopsital

Ryde, Australia

Kepler Universitätsklinikum GmbH

Linz, Austria

Results Point of Contact

Title: Lihua Li, Principal Clinical Scientist
Organization: Abbott

Study Officials

Stephen Worthley, M.D., Ph. D.
Macquarie University Hospital
PRINCIPAL INVESTIGATOR
Nicolas van Mieghem, M.D., Ph. D.
Erasmus Medical Center
PRINCIPAL INVESTIGATOR
Barathi Sethuraman
Abbott
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

434 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 9, 2021

Study Start

July 13, 2021

Actual (reported)

You may not qualify if:

Life expectancy is less than 2 years in the opinion of the Investigator.
Evidence of an acute myocardial infarction \[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\] within 30 days prior to index procedure.
Untreated clinically significant coronary artery disease requiring revascularization.
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the 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)
Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/ or end stage renal disease requiring chronic dialysis
Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.) \*
Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk \*
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) \*
Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography or CT \*
Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram
Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position \* (Note: Subjects with a bioprosthetic aortic valve may be included in the ViV cohort.)
Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) \*
+4 more criteria

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Primary Analysis Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Primary Analysis Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations