SOURCE XT REGISTRY

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01238497
First received: October 26, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Severe Aortic Stenosis
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SAPIEN XT™ Aortic Bioprosthesis Multi-region Outcome Registry

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Assess and track causality and sequelae of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effectiveness: observe trends in patient characteristics and outcomes over time [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: September 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238497

  Show 104 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Martyn Thomas, MB BS, FRCP, MD MTTWINS@aol.com
Principal Investigator: Olar Wendler, MD, PhD, FRCS olaf.wendler@kch.nhs.uk
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01238497     History of Changes
Other Study ID Numbers: 2010-10
Study First Received: October 26, 2010
Last Updated: April 1, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 22, 2014