Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

NCT01348438 | Completed DMC

• 1 other identifier: ENG CIP-001
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 9

Brief Summary

The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement.

Conditions

Aortic Valve Stenosis

Keywords

high risk; surgical valve replacement

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause mortality within 30 days post-implantation

  30 Days

Secondary Outcomes (2)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation

  6 months

• Device and procedure related Major Adverse Events

  30 days

Study Arms (1)

Single arm study

OTHER

Device: Medtronic Engager Transcatheter Aortic Valve Implantation System

Interventions

Medtronic Engager Transcatheter Aortic Valve Implantation System DEVICE

Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient \> 40 mmHg; max velocity \> 4m/s; aortic valve area ≤ 0.8 cm2.
• Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.
• Logistic EuroSCORE predicted risk for mortality of ≥20%, or comorbidity judged by the investigator to pose an absolute or relative contraindication for conventional aortic valve replacement.
• Patient is indicated for aortic valve implantation with a biological prosthesis (tissue valve) in accordance with the 2007 European Society of Cardiology (ESC) Guidelines for management of valvular heart disease.
• Age ≥ 18 years.
• Echocardiographically determined aortic annulus diameter of ≥19 mm and ≤ 26 mm in a long-axis view.

You may not qualify if:

• Congenital unicuspid or bicuspid aortic valve.
• Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in diameter.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Left ventricular ejection fraction \< 25%, as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available
• Hypertrophic obstructive cardiomyopathy.
• Patients with life expectancy less than 12 months due to an underlying non-cardiac comorbid disease.
• Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol.
• Sepsis or acute endocarditis.
• Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
• Renal insufficiency assessed by creatinine \> 2.5 mg/dl 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

Cliniques Universitaires Saint- Luc

Brussels, 1200, Belgium

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

Uniklinik Köln Heart Center

Cologne, 50937, Germany

Location

Universitätsklinikum Hamburg- Eppendorf

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

University of Zurich - Klinik für Herzchirurgie, UniversitätsSpital

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Holzhey D, Linke A, Treede H, Baldus S, Bleiziffer S, Wagner A, Borgermann J, Scholtz W, Vanoverschelde JL, Falk V. Intermediate follow-up results from the multicenter engager European pivotal trial. Ann Thorac Surg. 2013 Dec;96(6):2095-100. doi: 10.1016/j.athoracsur.2013.06.089. Epub 2013 Sep 7.

  PMID: 24021766 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Volkmar Falk, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Jean-Louis Vanoverschelde, Prof.

  Cliniques Universitaires Saint-Luc, Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: September 12, 2011
• Primary Completion: February 28, 2013
• Study Completion: January 25, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

IL (1); DE (6); BE (1); CH (1)