Clinical trial NCT00820599: PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Sapien Valve
Cardiovascular Diseases
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Transfemoral
Transcatheter
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 214
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"), 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.

Detailed description: Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007.

Clinical Sites: Up to 11 sites in Europe

Eligibility criteria: Inclusion Criteria:

All candidates for this study must meet all of the following inclusion criteria:

1. 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%.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. 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.
4. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

1. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
2. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
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).

Primary outcomes:
measure: Number of Deaths
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With a Stroke
timeFrame: 30 days from the index procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Paris
country: France
facility: Hospital Bichat Claude Bernard
city: Rouen
country: France
facility: CHU Hospital Charles Nicolle
city: Toulouse
country: France
facility: Clinique Pasteur
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
city: Karlsruhe
country: Germany
facility: City Clinics Karlsruhe
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Munich
country: Germany
facility: Schwabing Clinic
city: London
country: United Kingdom
facility: St. Thomas' Hospital - NHS Trust
city: London
country: United Kingdom
facility: Kings College Hospital - NHS Trust
Study officials:
affiliation: Cardiology Clinic of Schwabing Clinic
name: Prof. Dr. Stefan Sack
role: STUDY_DIRECTOR
affiliation: Edwards Lifesciences SA
name: Isabelle Fourthin
role: STUDY_DIRECTOR
References: