NCT00820599

Brief Summary

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
4 countries

11 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

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

January 8, 2009

Results QC Date

September 27, 2020

Last Update Submit

October 27, 2020

Conditions

Aortic Valve Stenosis

Keywords

Sapien ValveCardiovascular DiseasesValvular Heart DiseaseAortic StenosisHeart Valve TherapyTransfemoralTranscatheter

Outcome Measures

Primary Outcomes (1)

  • Number of Deaths

    Number of death at 30-days from the index procedure.

    30 days

Secondary Outcomes (1)

  • Number of Participants With a Stroke

    30 days from the index procedure

Study Arms (1)

TAVR

EXPERIMENTAL

Transaortic Valve Replacement

Device: Sapien XT™ transcatheter heart valve and delivery system

Interventions

Sapien XT™ transcatheter heart valve and delivery systemDEVICE
TAVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is \> 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of \> 20%.
  • Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  • The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
  • Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

You may not qualify if:

  • Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
  • Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst

Aalst, 9300, Belgium

Location

Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Hospital Bichat Claude Bernard

Paris, 75018, France

Location

CHU Hospital Charles Nicolle

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

City Clinics Karlsruhe

Karlsruhe, 76185, Germany

Location

Heart Center Leipzig

Leipzig, 04829, Germany

Location

Schwabing Clinic

Munich, 80804, Germany

Location

St. Thomas' Hospital - NHS Trust

London, SE1 7EH, United Kingdom

Location

Kings College Hospital - NHS Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve StenosisCardiovascular DiseasesHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Edwards THV Clinical Affairs
Organization
Edwards Lifesciences
THV_CT.gov@edwards.com
949-250-2500

Study Officials

  • Prof. Dr. Stefan Sack

    Cardiology Clinic of Schwabing Clinic

    STUDY DIRECTOR

  • Isabelle Fourthin

    Edwards Lifesciences SA

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
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

January 8, 2009

First Posted

January 12, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2010

Study Completion

March 1, 2016

Last Updated

November 2, 2020

Results First Posted

November 2, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)FR(4)BE(1)DE(4)