PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Aortic Valve Stenosis Clinical Trial

Official title:

Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820599
• Other study ID #: 2008-04
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: March 2016

Study information

• Verified date: October 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 2016
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Sapien XT™ transcatheter heart valve and delivery system

Locations

Country	Name	City	State
Belgium	Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst	Aalst
France	Institut Hospitalier Jacques Cartier	Massy
France	Hospital Bichat Claude Bernard	Paris
France	CHU Hospital Charles Nicolle	Rouen
France	Clinique Pasteur	Toulouse
Germany	Hamburg University Cardiovascular Center	Hamburg
Germany	City Clinics Karlsruhe	Karlsruhe
Germany	Heart Center Leipzig	Leipzig
Germany	Schwabing Clinic	Munich
United Kingdom	Kings College Hospital - NHS Trust	London
United Kingdom	St. Thomas' Hospital - NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Deaths	Number of death at 30-days from the index procedure.	30 days
Secondary	Number of Participants With a Stroke	Total number of participates with a stroke.	30 days from the index procedure