Long Term Follow-up of the 23mm Portico™ Aortic Valve Imp... | NCT01497418

Studies
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

NCT01497418

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Mar 2014Actual

First Submitted Date

Dec 2, 2011

First Submission Date that Met QC Criteria

Dec 19, 2011

First Posted Date

Dec 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Collect and evaluate the long term safety data.

Detailed Description

The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart	Data will be collected at 3 months, 6 months, and 12 months post-implant.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has given written study Informed Consent for participation prior to any study procedures.
Subject is ≥ 18 years of age or legal age in host country at time of consent.
Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

Exclusion Criteria:

Subject currently participating in another investigational device or drug study.
Subject is unable or unwilling to return for the required follow-up visits.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients that are candidate for implantation or have been implanted with the St. Jude Medical 23mm Portico Transcatheter heart valve.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Webb, MD	Providence Health Care - St. Paul's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
l'Institut universitaire de cardiologie et de pneumologie de Québec		Québec			Canada
St. Paul's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided