Engager Direct Aortic Clinical Study

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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Engager™ aortic valve

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Třinec, Czechia, 739 61
    • Nemocnice Podlesí a.s.
• Germany
  • Halle, Germany, 06120
    • University Hospital Halle
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • Munich, Germany, 80636
    • Deutsches Herzzentrum München
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St. Thomas' Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Engager™ aortic valve; Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach	Device: Engager™ aortic valve; Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Hendrik Treede, MD, University Hospital Halle, Germany; Principal Investigator: David Holzhey, MD, Leipzig Heart Institute, Germany; Principal Investigator: Sabine Bleiziffer, MD, German Heart Center Munich, Germany; Principal Investigator: Marian Branny, MD, Nemocnice Podlesi, Trinec, Czech Republic; Principal Investigator: Neil Moat, MD, Royal Brompton Hospital, London, United Kingdom; Principal Investigator: Vinayak Bapat, MD, St. Thomas' Hospital, London, United Kingdom

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: RAE00807