Engager Direct Aortic Clinical Study

NCT ID: NCT01789567

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-30

Brief Summary

To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.

Detailed Description

To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach in patients with symptomatic severe aortic valve stenosis at high or extreme risk for surgical aortic valve replacement for which treatment via direct aortic access is preferred.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Engager™ aortic valve

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Group Type: OTHER

Engager™ aortic valve

Intervention Type: DEVICE

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Interventions

Engager™ aortic valve

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Severe aortic stenosis as defined by Doppler echocardiography: aortic valve area ≤ 0.8 cm2 (or AVA index ≤ 0.5 cm2/m2), or mean gradient ≥ 40 mmHg, or max velocity ≥ 4m/s
• NYHA Functional Class II or greater;
• Logistic EuroSCORE I ≥ 20%, or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement;
• Non-calcified ascending aortic site ≥ 50 mm from the aortic valve basal plane;
• Age ≥ 18 years;
• The patient has been informed of the nature of the study and has consented to participate, authorizing the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form"). Patient should understand the implications of participating in the study and should be legally competent to provide informed consent.

Exclusion Criteria

• Unicuspid or bicuspid aortic valve;
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
• Left ventricular ejection fraction < 25%;
• Left ventricular outflow obstruction, such as Hypertrophic Obstructive Cardiomyopathy and severe septal hypertrophy;
• Mitral or tricuspid regurgitation greater than 2+ by angiography or moderate by echocardiography;
• Patients with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease;
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol or contrast medium that cannot be adequately controlled with pre-medication;
• Sepsis or acute endocarditis;
• Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy;
• Renal insufficiency assessed by creatinine clearance < 20 ml/min and/or end-stage renal disease requiring chronic dialysis;
• Active peptic ulcer or GI bleeding within 3 months from the planned index procedure;
• Untreated clinically significant coronary artery disease requiring revascularization;
• Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance;
• Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater;
• Need for emergency surgery, cardiac or non-cardiac;
• History of myocardial infarction in the last 6 weeks;
• History of TIA or CVA in the last 6 months;
• Therapeutic invasive cardiac procedure, with the exception of BAV, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents;
• Pre-existing prosthetic heart valve or prosthetic ring in any position;
• Patent RIMA or pre-existing patent RIMA graft at direct aortic access site and/or trajectory;
• Patient refuses a blood transfusion;
• Pregnant or breastfeeding women;
• Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hendrik Treede, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Halle, Germany

David Holzhey, MD

Role: PRINCIPAL_INVESTIGATOR

Leipzig Heart Institute, Germany

Sabine Bleiziffer, MD

Role: PRINCIPAL_INVESTIGATOR

German Heart Center Munich, Germany

Marian Branny, MD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Podlesi, Trinec, Czech Republic

Neil Moat, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton Hospital, London, United Kingdom

Vinayak Bapat, MD

Role: PRINCIPAL_INVESTIGATOR

St. Thomas' Hospital, London, United Kingdom

Locations

Nemocnice Podlesí a.s.

Třinec, , Czechia

University Hospital Halle

Halle, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Deutsches Herzzentrum München

Munich, , Germany

St. Thomas' Hospital

London, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

Countries

Czechia; Germany; United Kingdom

Other Identifiers

RAE00807

Identifier Type: -

Identifier Source: org_study_id