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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01497418
First received: December 2, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Collect and evaluate the long term safety data.


Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Data will be collected at 3 months, 6 months, and 12 months post-implant.


Enrollment: 2
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subject currently participating in another investigational device or drug study.
  2. Subject is unable or unwilling to return for the required follow-up visits.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497418

Locations
Canada
l'Institut universitaire de cardiologie et de pneumologie de Québec
Quebec, Canada
St. Paul's Hospital
Vancouver, Canada
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: John Webb, MD Providence Health Care - St. Paul's Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01497418     History of Changes
Other Study ID Numbers: 1102
Study First Received: December 2, 2011
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on April 17, 2014