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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497418
First Posted: December 22, 2011
Last Update Posted: September 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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 ]
    Data will be collected at 3 months, 6 months, and 12 months post-implant.


Enrollment: 2
Study Start Date: December 2011
Study Completion Date: March 2014
Primary Completion Date: July 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01497418     History of Changes
Other Study ID Numbers: 1102
First Submitted: December 2, 2011
First Posted: December 22, 2011
Last Update Posted: September 19, 2014
Last Verified: September 2014

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