Engager Direct Aortic Clinical Study

Aortic Valve Stenosis Clinical Trial

Official title:

Engager Direct Aortic Clinical Study: Medtronic Engager™ Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789567
• Other study ID #: RAE00807
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: June 2015

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Engager™ aortic valve
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Locations

Country	Name	City	State
Czechia	Nemocnice Podlesí a.s.	Trinec
Germany	University Hospital Halle	Halle
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum München	Munich
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Czechia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device Success According to VARC2	Device success is a composite of: Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient <20 mmHg or peak velocity <3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation)	30 days post-procedure
Other	Composite 30-day Safety Endpoint According to VARC2	Percentage of Participants with any of the following Safety Events within 30-days post-procedure: All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)	30-days post-procedure
Other	Composite Clinical Efficacy Endpoint After 30 Days According to VARC2	Percentage of Participants with any of the following Safety Events after 30-days post-procedure: All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure	30-days post-procedure
Primary	Acute Delivery System Success	Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.	Within 30 days of implant procedure