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.
Information provided by (Responsible Party):
St. Jude Medical
First received: December 2, 2011
Last updated: March 12, 2014
Last verified: March 2014
Collect and evaluate the long term safety data.
||Observational Model: Cohort
||Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
Primary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients that are candidate for implantation or have been implanted with the St. Jude Medical 23mm Portico Transcatheter heart valve.
- 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
- Subject currently participating in another investigational device or drug study.
- Subject is unable or unwilling to return for the required follow-up visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497418
|l'Institut universitaire de cardiologie et de pneumologie de Québec
|Quebec, Canada |
|St. Paul's Hospital
|Vancouver, Canada |
St. Jude Medical
||John Webb, MD
||Providence Health Care - St. Paul's Hospital
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2011
||March 12, 2014
||Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Aortic Valve Stenosis
Heart Valve Diseases
Ventricular Outflow Obstruction