Engager Direct Aortic Clinical Study

• ClinicalTrials.gov Identifier: NCT01789567
• Recruitment Status: Completed
• First Posted: February 12, 2013
• Results First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Sponsor: Medtronic Bakken Research Center
• Information provided by (Responsible Party): Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Aortic Valve Stenosis	Device: Engager™ aortic valve	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Engager Direct Aortic Clinical Study: Medtronic Engager™ Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach
• Study Start Date: May 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Acute Delivery System Success [ Time Frame: Within 30 days of implant procedure ]
   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.

Other Outcome Measures:

1. Device Success According to VARC2 [ Time Frame: 30 days post-procedure ]

   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)

2. Composite 30-day Safety Endpoint According to VARC2 [ Time Frame: 30-days post-procedure ]

   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)

3. Composite Clinical Efficacy Endpoint After 30 Days According to VARC2 [ Time Frame: 30-days post-procedure ]

   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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Czechia

Nemocnice Podlesí a.s.

Třinec, Czechia, 739 61

Germany

University Hospital Halle

Halle, Germany, 06120

Herzzentrum Leipzig

Leipzig, Germany, 04289

Deutsches Herzzentrum München

Munich, Germany, 80636

United Kingdom

St. Thomas' Hospital

London, United Kingdom, SE1 7EH

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Sponsors and Collaborators

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

More Information

• Responsible Party: Medtronic Bakken Research Center
• ClinicalTrials.gov Identifier: NCT01789567
• Other Study ID Numbers: RAE00807
• First Posted: February 12, 2013
• Results First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Last Verified: October 2017

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction