NCT01238835

Brief Summary

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
4 countries

20 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 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5.1 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

1.4 years

First QC Date

January 26, 2010

Results QC Date

September 27, 2020

Last Update Submit

October 27, 2020

Conditions

Aortic Valve Stenosis

Keywords

Sapien XT ValveValvular Heart DiseaseAortic StenosisHeart Valve TherapyTransapicalTranscatheter

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

Study Arms (1)

TAVR-TA

EXPERIMENTAL

Transcatheter valve replacement with transapical access

Device: SAPIEN XT™ Transapical aortic valve replacement

Interventions

SAPIEN XT™ Transapical aortic valve replacementDEVICE

Transcatheter aortic valve implantation via the transapical approach

Also known as: Sapien XT, Next generation Ascendra delivery system inclusive accessory
TAVR-TA

Eligibility Criteria

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

You may qualify if:

  • EuroSCORE of ≥ 15 %
  • Severe senile degenerative aortic valve stenosis
  • Symptomatic aortic valve stenosis
  • Informed consent
  • Compliance

You may not qualify if:

  • Logistic Euroscore \> 40 %
  • Evidence of an acute myocardial infarction
  • Congenital unicuspid or congenital bicuspid valve/ non-calcified
  • Mixed aortic valve disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Medizinische Universitat Wien Univ.Klinik f.Chirurgie

Vienna, 1019, Austria

Location

Hôspital Bichat

Paris, 75018, France

Location

Herz-Und Gefasszentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Herz-und-Gefass Klinik

Bad Neustadt an der Saale, 97616, Germany

Location

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Schüchtermann-Klinik

Bad Rothenfelde, 49214, Germany

Location

Heart Center University Cologne

Cologne, 50924, Germany

Location

Herzzentrum Dresden GmbH

Dresden, 01307, Germany

Location

University Clinic Erlangen

Erlangen, 91054, Germany

Location

University Hospital Essen, West German Heart Center

Essen, 45122, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Cardiac Surgery Karlsruhe

Karlsruhe, 76185, Germany

Location

Heart Center Leipzig

Leipzig, 04829, Germany

Location

German Heart Center Munich

Munich, 80636, Germany

Location

University Hospital Munich-Grosshadern

Munich, 81377, Germany

Location

Hospital Munich-Bogenhausen

Munich, 81925, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

St. Thomas' Hospital - NHS Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular 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. Thomas Walther

    Kerckhoff Klinik

    PRINCIPAL INVESTIGATOR

  • Dr. Olaf Wendler

    King's College London

    PRINCIPAL INVESTIGATOR

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 26, 2010

First Posted

November 11, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2011

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

AU(1)DE(16)FR(1)GB(2)