Clinical trial NCT01238835: PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Sapien XT Valve
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Transapical
Transcatheter
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.

Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.

Eligibility criteria: Inclusion:

1. EuroSCORE of ≥ 15 %
2. Severe senile degenerative aortic valve stenosis
3. Symptomatic aortic valve stenosis
4. Informed consent
5. Compliance

Exclusion:

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

Primary outcomes:
measure: Number of Deaths
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With a Stroke
timeFrame: 30-days
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universitat Wien Univ.Klinik f.Chirurgie
city: Paris
country: France
facility: Hôspital Bichat
city: Bad Bevensen
country: Germany
facility: Herz-Und Gefasszentrum Bad Bevensen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz-und-Gefass Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Cologne
country: Germany
facility: Heart Center University Cologne
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
city: Erlangen
country: Germany
facility: University Clinic Erlangen
city: Essen
country: Germany
facility: University Hospital Essen, West German Heart Center
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Karlsruhe
country: Germany
facility: Cardiac Surgery Karlsruhe
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Munich
country: Germany
facility: German Heart Center Munich
city: Munich
country: Germany
facility: University Hospital Munich-Grosshadern
city: Munich
country: Germany
facility: Hospital Munich-Bogenhausen
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: London
country: United Kingdom
facility: St. Thomas' Hospital - NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Kerckhoff Klinik
name: Prof. Dr. Thomas Walther
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Dr. Olaf Wendler
role: PRINCIPAL_INVESTIGATOR
References: