CoreValve Advance International Post Market Study

Severe Aortic Stenosis Clinical Trial

Official title:

CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074658
• Other study ID #: Advance
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: October 25, 2017
• Start date: March 2010
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Description:

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1015
• Est. completion date: May 2017
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with severe aortic valve stenosis requiring treatment

• Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context

• Patient is above the minimum age as required by local regulations to be participating in a clinical study

• The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

Exclusion Criteria:

• Currently participating in another trial

• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

• Pregnancy

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Stenosis

Intervention

Device:
• Medtronic CoreValve System
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Locations

Country	Name	City	State
Belgium	Antwerpen UZA	Antwerp
Belgium	ZNA Antwerpen Middelheim	Antwerpen
Belgium	CHU Sart Tillman	Liege
Colombia	Angiografia de Occidente	Cali
Denmark	Rigshospitalet	Copenhagen
France	Hopital Henri Mondor	Creteil
France	Hopital Cardiologique	Lille
France	Hopital Louis Pradel	Lyon
France	Institut Hospitalier Jacques Cartier	Massy
France	Groupe Hospitalier Pitie-Salpetriere	Paris Cedex
France	Clinique Pasteur	Toulouse Cedex
Germany	Universitätsklinikum Aachen	Aachen
Germany	Bernau Herzzentrum Brandenburg	Bernau b. Berlin
Germany	CardioVascular Center Frankfurt	Frankfurt
Germany	Asklepios Klinik St. Georg Hamburg	Hamburg
Germany	Universitat Leipzig Herzzentrum	Leipzig
Germany	Deutsches Herzzentrum Munchen	Munchen
Germany	Helios Herzzentrum Siegburg Gmbh	Siegburg
Greece	Onassis cardiac surgery center	Athens
Israel	Hadassah Medical Center	Jerusalem
Israel	Ichilov Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel Aviv
Italy	Azienda Ospedaliere Spedali Civili di Brescia	Brescia
Italy	Policlinico Vittorio Emanuele, P.O. Ferrarotto	Catania
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Ospedale Civile	Legnano
Italy	Fondazione Centro San Raffaele	Milano
Italy	Istituto Clinico S.Ambrogio	Milano
Italy	Ospedale Niguarda Ca'Granda	Milano
Italy	Istituto Clinico Humanitas	Rozzano
Netherlands	AMC Ziekenhuis	Amsterdam
Netherlands	Amphia Breda	Breda
Netherlands	Catharina Hospital	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Portugal	Hospital de Santa Cruz	Lisbon
Portugal	Centro Hospitalar de Vila Nova de Gaia	Porto
Switzerland	Universtiy Hospital Isel Bern	Bern
Switzerland	Universitätsspital Zürich	Zurich
United Kingdom	Brighton and Sussex Hospital	Brighton
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Leicester Hospital	Leicester
United Kingdom	St. George`s Hospital	London
United Kingdom	The Heart Hospital	London
United Kingdom	Newcross Hospital Wolverhampton	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Belgium,  Colombia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac & Cerebrovascular Events (MACCE)	MACCE is defined as a composite of: All cause mortality; Myocardial Infarction (Q-wave and non-Q-wave); Emergent cardiac surgery or percutaneous re-intervention; Stroke; The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.	30 days
Secondary	Percentage of Participants With Device Success	Device Success is defined as a composite of: Successful device delivery; Stable device placement; Intact retrieval of delivery catheter; Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and = 2 aortic regurgitation	up to 24 hours
Secondary	Percentage of Participants With Procedural Success	Procedural success, defined as device success with absence of in-hospital MACCE	up to 30 days