NCT01497418

Brief Summary

Collect and evaluate the long term safety data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

December 2, 2011

Last Update Submit

February 1, 2019

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Canada

Location

St. Paul's Hospital

Vancouver, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • John Webb, MD

    Providence Health Care - St. Paul's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 22, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

March 1, 2014

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

CA(2)