CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

Aortic Valve Stenosis Clinical Trial

Official title:

Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209298
• Other study ID #: MED-02
• Status: Completed
• Start date: November 2014
• Est. completion date: December 3, 2018

Study information

• Verified date: April 2019
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

Description:

To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 3, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is > 18 years old

• Patient has a symptomatic degeneration of aortic bioprosthesis

• Acceptable candidate for elective treatment with the Medtronic CoreValveTM System (according to the most recent version of the Medtronic CoreValveTM Instructions For Use) and in conformity with the local regulatory and reimbursement context

• Logistical Euroscore > 20% or STS > 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk

• The patient or legal representative has been informed of the nature of the procedure and 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")

• The patient is willing and able to comply with requirements of the study, including the 24 months follow-up

• Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis

Exclusion Criteria:

• Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated

• Patient in whom heart team considers that risk of TAVI is too high with a particular attention for the risk of coronary occlusion

• Patient with prior endocarditis on failed bioprosthesis

• Patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year)

• Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices

• Patient with severe mitral disease associated with severe pulmonary hypertension

• Acute coronary syndrome less than 7 days before intervention

• Currently participating in another investigational drug or device study.

• Patient with significant paravalvular regurgitation

• Patient in whom internal diameter prosthesis is equal to 17 mm

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• CoreValve Transcatheter Valve
Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.

Locations

Country	Name	City	State
France	CHU Brest	Brest
France	CHU Clermont	Clermont-Ferrand
France	CHU Mondor	Créteil
France	Clinique Parly 2 Le Chesnay	Le Chesnay
France	CHU Lille	Lille
France	HCL CHU Louis Pradel	Lyon
France	CHU La Timone	Marseille
France	Hopital Jacques Cartier	Massy
France	CHU de Nantes	Nantes
France	CHU La Pitié Salpétrière	Paris
France	CHU Bordeaux	Pessac
France	CHU Rennes	Rennes
France	CHU Rangueil Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	Tonkin Clinic	Villeurbanne
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Sana-Herzzentrum Cottbus	Cottbus
Germany	Hamburg Eppendorf	Hamburg
Germany	Herzzentrum Leipzig GmbH Leipzig	Leipzig
Israel	Rabin Medical center	Petah Tikva
Israel	Sheba Medical Center	Tel Hashomer
Italy	Brescia Hospital	Brescia
Italy	Policlinico San Donato	Milano
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

France,  Germany,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular death		30 days post-index procedure
Primary	Lack of significant aortic stenosis or insufficiency		1 year Follow-up
Secondary	Safety composite endpoint based on VARC-II endpoint definitions		At 30 days and during follow-up visits
Secondary	Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient		At 30 days and during follow-up visits