Loading search results

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
+15 more other outcomes

Interventions

Portico Valve and FlexNav™ Delivery SystemDevice

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

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

Eligibility Criteria

Age21 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Study Sites (6)

Rigshospitalet

Copenhagen, 2100, Denmark

Policlinico San Donato

San Donato Milanese, Lombard, 20097, Italy

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Universitaets Spital Zuerich

Zurich, 8091, Switzerland

Morriston Hospital - ABM University Health Board

Morriston, Swansea, SA6 6NL, United Kingdom

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

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).

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

FlexNav EU CE Mark Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (18)

Study Arms (1)

Portico valve and FlexNav™ Delivery System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

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

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (18)

Study Arms (1)

Portico valve and FlexNav™ Delivery System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

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