This trial is active, not recruiting.

Conditions severe, symptomatic, calcific aortic stenosis
Treatment tavr implantation of the transcatheter aortic valve prosthesis
Phase phase 4
Sponsor Edwards Lifesciences
Collaborator American College of Cardiology (ACC)
Start date September 2013
End date February 2014
Trial size 5000 participants
Trial identifier NCT02184442, 2011-THV-01-US /2012-THV-01-US, PMA # P110021 and P100041


The purpose of this post approval study is to determine the safety, effectiveness and learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable patients with Severe Symptomatic Native Aortic Stenosis via all access sites.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment
SAPIEN valve with the Retroflex delivery system or the Ascendra delivery system
tavr implantation of the transcatheter aortic valve prosthesis
Inoperable and high risk operable patients requiring the transcatheter aortic heart valve replacement

Primary Outcomes

The clinical event of stroke
time frame: 30 days
The clinical event of stroke
time frame: 1 year

Secondary Outcomes

-VARC composite safety -Major vascular complications -Stroke
time frame: 30 days and 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients must meet the fundamental enrollment criteria of severe, symptomatic, calcific aortic stenosis with quantifiable and documented source records - Upon meeting these eligibility criteria, the heart team shall then determine the patient's risk for operative morbidity and mortality - Details of eligibility including contraindications are provided in the product Instructions for Use which are included with each SAPIEN™ THV and delivery system.

Additional Information

Official title Assessment of Safety, Effectiveness, Adherence to Indication and Learning Curve of the SAPIEN™ THV With Retroflex for Inoperable Patients and With RetroFlex or Ascendra for High Risk Operable Patients Post Approval Period (US)
Description The following concerns will be addressed in this trial: 1) long term (5 year) valve implant durability with echocardiography, 2) long-term (5 year) quality of life assessment with KCCQ-12 instrument, 3) assessment of learning curve in the post approval setting (utilizing the VARC composite for procedural success as a benchmark), 4) assessment of adherence to label indication in the post approval setting (using assessment of baseline characteristics) and 5) assessment of stroke in the post approval setting. Study patients will undergo clinical follow-up at discharge, 30 days, 1 year and then annually for a minimum of 5 years (TVT national registry-CMS Linkage).
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.