NCT03314857

Brief Summary

To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 15, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

October 16, 2017

Results QC Date

June 29, 2020

Last Update Submit

August 23, 2023

Conditions

Aortic StenosisSymptomatic Aortic StenosisAortic Regurgitation

Keywords

TAVITAVRCHINASAPIEN XTHigh RiskTranscatheter aortic valve implantationTranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

  • All-cause Mortality

    All of the deaths that occurred in this population regardless of the cause.

    30 days

Secondary Outcomes (2)

  • Cardiovascular Mortality

    30 days

  • Number of Participates With a Stroke

    30 days

Study Arms (1)

Patients with SAPIEN XT THV

EXPERIMENTAL

Patients will be treated with Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system

Device: SAPIEN XT THV with the NovaFlex+ delivery system

Interventions

SAPIEN XT THV with the NovaFlex+ delivery systemDEVICE

Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system

Patients with SAPIEN XT THV

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE ≤ 40. If STS score is below 8 and/or Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
  • Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA \< 0.8 cm2, Indexed AVA \<0.5 cm2/m2, mean gradient \> 40mmHg, or peak aortic jet velocity \> 4.0m/sec.
  • NYHA Functional Class II or greater.
  • The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
  • The study patient agrees to comply with all required post procedure follow-up visits.

You may not qualify if:

  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
  • Aortic valve is a congenital unicuspid or is non-calcified.
  • Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
  • Anomalous coronary artery that would interfere with proper placement of the valve.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

WestChina Hospital, Sichuan University

Sichuan, Chengdu, China

Location

Fuwai Hospital, CAMS&PUMC

Beijing, China

Location

The Second Affiliated Hospital of Zhejiang University School of

Hangzhou, China

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Director of Research
Organization
Edwards Lifesciences
THV_CT.gov@edwards.com
949-250-2500

Study Officials

  • Runlin Gao

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

September 18, 2017

Primary Completion

July 6, 2018

Study Completion

June 15, 2023

Last Updated

September 5, 2023

Results First Posted

July 15, 2020

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)