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SOURCE XT REGISTRY

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ClinicalTrials.gov Identifier: NCT01238497
Recruitment Status : Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

Condition or disease Intervention/treatment
Severe Aortic Stenosis Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Detailed Description:
Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.

Study Type : Observational
Actual Enrollment : 2954 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
Actual Study Start Date : September 2010
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Registry 1 - SOURCE XT
Registry 1: All patients implanted with a SAPIEN XT valve, via Transfemoral access using NovaFlex (for 23mm and 26mm valve), or via Transapical access using Ascendra2 (23mm, 26mm and 29mm valve)
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Other Name: TAVI Transcatheter Aortic Valve Implantation
Registry 2 - Ascendra+
Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve)
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
Other Name: TAVI Transcatheter Aortic Valve Implantation
Registry 3 - NovaFlex+ 29 mm
Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for transfemoral access and requiring a 29mm valve.
Other Name: TAVI Transcatheter Aortic Valve Implantation



Primary Outcome Measures :
  1. Assess and track causality and sequelae of major adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Effectiveness: observe trends in patient characteristics and outcomes over time [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic aortic stenosis
Criteria

Inclusion Criteria:

  • The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are "non-operable"

Exclusion Criteria:

  • Non-valvular or congenital aortic stenosis
  • Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve
  • Severe (>3+) mitral insufficiency or aortic regurgitation > 3+
  • Active bacterial endocarditis or other active infections
  • Severe ventricular dysfunction with ejection fraction < 20%
  • Coronary artery disease-related unstable angina
  • Inability to tolerate anticoagulation / antiplatelet therapy

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): NCT01238497


  Show 104 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Olaf Wendler, MD, PhD, FRCS olaf.wendler@kch.nhs.uk

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01238497     History of Changes
Other Study ID Numbers: 2010-10
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Edwards Lifesciences:
SAPIEN XT™
Transfemoral
NovaFlex
NovaFlex+
NF
NF+
Transapical
Transaortic
Ascendra2
Ascendra+
Asc+
aortic stenosis
aortic valve
Transcatheter Heart Valve
THV

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