Overview

This trial is active, not recruiting.

Condition severe aortic stenosis
Treatments tavr implantation of the transcatheter aortic valve prosthesis
Sponsor Edwards Lifesciences
Start date September 2010
End date August 2014
Trial size 2954 participants
Trial identifier NCT01238497, 2010-10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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)
tavr implantation of the transcatheter aortic valve prosthesis TAVI Transcatheter Aortic Valve Implantation
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve)
tavr implantation of the transcatheter aortic valve prosthesis TAVI Transcatheter Aortic Valve Implantation
Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+
tavr implantation of the transcatheter aortic valve prosthesis TAVI Transcatheter Aortic Valve Implantation
Patients eligible for transfemoral access and requiring a 29mm valve.

Primary Outcomes

Measure
Assess and track causality and sequelae of major adverse events
time frame: 30 days

Secondary Outcomes

Measure
Effectiveness: observe trends in patient characteristics and outcomes over time
time frame: One year

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
Principal investigator Olaf Wendler, MD, PhD, FRCS
Description Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.