Back to results

Engager Direct Aortic Clinical Study

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Engager™ aortic valve

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nemocnice Podlesí a.s.
University Hospital Halle
Herzzentrum Leipzig
Deutsches Herzzentrum München
St. Thomas' Hospital
Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Engager™ aortic valve

Arm Description

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01789567

First Posted

February 6, 2013

Last Updated

October 27, 2017

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01789567

Brief Title

Engager Direct Aortic Clinical Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Engager™ aortic valve

Arm Type

Other

Arm Description

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Intervention Type

Device

Intervention Name(s)

Engager™ aortic valve

Intervention Description

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Primary Outcome Measure Information:

Title

Acute Delivery System Success

Description

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.

Time Frame

Within 30 days of implant procedure

Other Pre-specified Outcome Measures:

Title

Device Success According to VARC2

Description

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)

Time Frame

30 days post-procedure

Title

Composite 30-day Safety Endpoint According to VARC2

Description

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)

Time Frame

30-days post-procedure

Title

Composite Clinical Efficacy Endpoint After 30 Days According to VARC2

Description

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

Time Frame

30-days post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: