Engager Direct Aortic Clinical Study

NCT01789567 | Completed Results DMC

• 1 other identifier: RAE00807
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Device Success According to VARC2

  30 days post-procedure

• Composite 30-day Safety Endpoint According to VARC2

  30-days post-procedure

• Composite Clinical Efficacy Endpoint After 30 Days According to VARC2

  30-days post-procedure

Study Arms (1)

Engager™ aortic valve

OTHER

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Device: Engager™ aortic valve

Interventions

Engager™ aortic valve DEVICE

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Engager™ aortic valve

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 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (6)

Nemocnice Podlesí a.s.

Třinec, 739 61, Czechia

Location

University Hospital Halle

Halle, 06120, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kitty Schapira
• Organization: Medtronic Bakken Research Center

kitty.schapira@medtronic.com

+31433566802

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: February 6, 2013
• First Posted: February 12, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2017-10

Locations

CZ (1); DE (3); GB (2)