FlexNav EU CE Mark Study

NCT03724812 | Completed Results

• 1 other identifier: ABT-CIP-10260
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 6

Brief Summary

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

Aortic Stenosis; FlexNav™ Delivery System; Portico Delivery System; Transcatheter Aortic Valve Replacement; Heart Valve Disease; High surgical risk

Outcome Measures

Primary Outcomes (1)

• Major Vascular Complications

  Percentage of patients with a VARC-2 defined major vascular complication event

  At 30 days post index procedure

Other Outcomes (18)

• Non-hierarchical Composite Safety Endpoint

  30 days from the index procedure.

• All-Cause Mortality

  30 days from the index procedure

• Disabling Stroke

  30 days from index procedure

Study Arms (1)

Portico valve and FlexNav™ Delivery System

EXPERIMENTAL

Portico valve implantation with the second-generation FlexNav Delivery system

Device: Portico Valve and FlexNav™ Delivery System

Interventions

Portico Valve and FlexNav™ Delivery System DEVICE

Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach

Portico valve and FlexNav™ Delivery System

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have co-morbidities such that the local heart team concur the predicted risk of operative mortality is ≥15% or a minimum Society of Thoracic Surgeons (STS) score of 8%.
• a) A candidate who does not meet the STS score criteria of ≥ 8% may be included in the study if at least one surgeon in the local heart team concludes and documents the patient's predicted risk of operative mortality is ≥15%. The surgeon's assessment of operative comorbidities (including frailty indices) not captured by the STS score must be documented in the study case report form as well as in the patient medical record.
• Subject is of legal age or older for consent in the host country.
• Subject has senile degenerative aortic valve stenosis with echo-derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or doppler velocity index (DVI) \<0.25 and an initial aortic valve area (AVA) of ≤1.0 cm2 (indexed Effective Orifice Area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
• Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
• Subject's aortic annulus is 19-27mm diameter as measured by computed tomography (CT) conducted within 12 months prior to informed consent. If a CT i contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted.
• All candidates for Extreme Risk classification must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and
• After formal consultation with the local heart team (including at least one surgeon) it is agreed that medical factors preclude the subject from undergoing operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The local heart teams' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.

You may not qualify if:

• Candidates will be excluded if any of the following conditions are present:
• Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified as verified by echocardiography.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
• 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 LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
• 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.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Need for emergency surgery for any reason.
• Hypertrophic cardiomyopathy with or without obstruction (HOCM).
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Policlinico San Donato

San Donato Milanese, Lombard, 20097, Italy

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Universitaets Spital Zuerich

Zurich, 8091, Switzerland

Location

Morriston Hospital - ABM University Health Board

Morriston, Swansea, SA6 6NL, United Kingdom

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Angelic Roach
• Organization: Abbott

angelic.roach@abbott.com

+1 651 756 3379

Study Officials

• Francesco Bedogni, MD

  Policlinico San Donato

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: February 26, 2019
• Primary Completion: January 14, 2020
• Study Completion: February 10, 2021
• Last Updated: November 24, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); IT (1); CH (2); DK (1)