Aortic Valve StenosisNCT01789567

Engager Direct Aortic Clinical Study

A study testing Engager™ aortic valve in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Engager™ aortic valve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 6 sitesin 3 countries
Study dates: May 2013to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 23Show fewer

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.

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

Germany3 sites

University Hospital Halle
Halle, 06120
Herzzentrum Leipzig
Leipzig, 04289
Deutsches Herzzentrum München
Munich, 80636

Other trials in Germany

United Kingdom2 sites

St. Thomas' Hospital
London, SE1 7EH
Royal Brompton Hospital
London, SW3 6NP

Other trials in United Kingdom

Czechia1 site

Nemocnice Podlesí a.s.
Třinec, 739 61

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Conditions: Aortic Valve Stenosis
Being tested: Engager™ aortic valve
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Engager™ aortic valveDevice
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Study groups in NCT01789567
Study group	Role	What they receive
Engager™ aortic valve	Other	Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach Receives: Device: Engager™ aortic valve

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 30 days of implant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jun 2015

First posted12 Feb 2013 (estimated)
Study startMay 2013
Primary completionJul 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01789567
Sponsor's protocol ID: RAE00807
Status last verified: Oct 2017
First submitted: 6 Feb 2013
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Engager Direct Aortic Clinical Study: Medtronic Engager™ Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach
ClinicalTrials.gov ID: NCT01789567
Acronym / sponsor ID: RAE00807
Conditions: Aortic Valve Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jul 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 12 Feb 2013 (estimated)
Results: Posted 26 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Engager™ aortic valve	Other	Device: Engager™ aortic valveImplantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (23 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Engager™ aortic valveImplantation of the Medtronic Engager™ bioprosthesis via direct aortic approach	Device	Engager™ aortic valve

Primary outcome

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.

Results and safety

Results posted to the registry on 26 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engager™ Aortic Valve	20	14

Primary outcome: Acute Delivery System Success

Time frame: Within 30 days of implant procedure. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Engager™ Aortic Valve n = 20
Value	95.0 (75.1 to 99.9)

Population analysed: Analysis for this endpoint includes subjects with an implant attempt.

Adverse events

Time frame: Adverse event data were collected up to 1 year post-implant procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engager™ Aortic Valve	20 of 20 (100%)	20 of 20 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Aortic Valve Stenosis

Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hendrik Treede, MD principal investigator

University Hospital Halle, Germany

David Holzhey, MD principal investigator

Leipzig Heart Institute, Germany

Sabine Bleiziffer, MD principal investigator

German Heart Center Munich, Germany

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Engager™ aortic valve in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, United Kingdom, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Delivery System Success (time frame: Within 30 days of implant procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.