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

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ClinicalTrials.gov Identifier: NCT01497418
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
Collect and evaluate the long term safety data.

Condition or disease
Aortic Valve Stenosis

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.

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Official Title: Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
Study Start Date : December 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 [ Time Frame: 1 year ]
    Data will be collected at 3 months, 6 months, and 12 months post-implant.



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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.

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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01497418     History of Changes
Other Study ID Numbers: 1102
First Posted: December 22, 2011    Key Record Dates
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