Aortic Valve StenosisNCT02149654
Engager Align Post-market Clinical Study
An observational study of Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.
Trial summary
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment. Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market study. 250 Patients will have the Engager bioprosthesis implanted. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Engager Transcatheter Aortic Valve Implantation System
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Jan 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe aortic stenosis requiring treatment, who are selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve Implantation System are eligible to be included in this study.
Who may be able to join
- Patient can be included if ALL of the following criteria are met:
- Patient with severe aortic valve stenosis requiring treatment;
- Patient is an acceptable candidate for elective treatment with the Medtronic Engager Transcatheter Aortic Valve Implantation System and in conformity with the local regulatory requirements;
- Patient is above the minimum age as required by local regulations to be participating in a clinical study;
- The patient has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form or Data Release Form).
Who cannot join
- Patient will not be included if any of the following conditions exist:
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol of contrast medium that cannot be adequately controlled with pre-medication;
- Intracardiac mass, thrombus, or vegetation;
- Aortic aneurysm;
- Sepsis or acute endocarditis;
- Bleeding diathesis, or coagulopathy;
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- Cardiogenic shock, suspected cardiogenic shock;
- Unicuspid or bicuspid aortic valve;
- Pre-existing prosthetic heart valve in aortic position;
- Patient is currently enrolled in another investigational device or drug trial;
- Patients with life expectancy less than 12 months after TAVI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Engager ALIGN Study. To Characterize the Safety and Clinical Benefit of the Engager Transcatheter Aortic Valve Implantation System in a Real World Environment.
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market study.
250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1 month, 6 months, and 12 months after the procedure. The recruitment period will be approximately 12 months, so the total study duration will be 24 months.
Read the detailed description
The study objective is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.
The primary endpoint of this study is all-cause mortality at 30 days or during index hospitalization.
Secondary endpoints of this study are:
- Device success according to VARC2 is defined as:
- absence of procedural mortality (all-cause mortality at discharge, 30 days or during index hospitalization), AND
- correct positioning of the Engager bioprosthesis in the proper anatomic location, AND
- Engager bioprosthesis performing as intended (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe regurgitation).
- Composite early safety (at 30 days) according to VARC2 includes the following components:
- 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)
- Clinical efficacy according to VARC2 at 6 months and 1 year is defined as:
- all-cause mortality
- all stroke
- hospitalizations for valve-related symptoms or worsening congestive heart failure (CHF)
- NYHA class III or IV
- valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area (EOA) ≤0.9-1.1 cm² and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
- Time-related valve safety accordingly to VARC2 at 6 months and 1 year is defined as:
- Structural valve deterioration
- Valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, (EOA) ≤0.9-1.1 cm² and/or (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
- Requiring repeat procedure (TAVI or SAVR)
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thrombo-embolic events (e.g. stroke)
- VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)
- All-cause mortality at 6 months and 1 year
- Cardiovascular mortality at 30 days, 6 months and 1 year
- Incidence of TAVI-related complications at 30 days, 6 months and 1 year:
- Myocardial infarction
- Periprocedural and spontaneous stroke
- Life-threatening, major and minor bleedings
- Acute kidney injury state 1, 2 and 3
- Apical and vascular complications
- Conduction disturbances
- Conversion to open-heart surgery
- Unplanned use of cardiopulmonary bypass
- Coronary obstruction and dissection
- Ventricular septal perforation
- Mitral valve apparatus damage or dysfunction
- Cardiac tamponade
- Endocarditis
- Valve thrombus
- Valve migration, embolization or ectopic valve deployment
- Valve in valve deployment
- Total, transvalvular and paravalvular regurgitation as measured by TTE at 30 days and 1 year
- Mean aortic valve gradient, peak velocity and effective orifice area as measured by TTE at 30 days and 1 year
- Engager implant depth as measured by standard of care angiography at the end of implant procedure
- Incidence and rationale for permanent pacemaker implantation after Engager implant procedure
- Changes in Quality of Life as measured by the EQ5D questionnaire at baseline, discharge, 30 days, 6 months and 1 year
- Length of stay during index hospitalization (ICU and general ward)
- Incidence of re-hospitalization at 30 days, 6 months and 1 year
Subject population All patients with severe aortic stenosis requiring treatment, who are selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve Implantation System are eligible to be included in this study.
Treatment The Engager Transcatheter Aortic Bioprosthesis will be implanted using the Engager Transcatheter Delivery System. The bioprosthesis is delivered transapically on a catheter during a beating heart procedure.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Engager Transcatheter Aortic Valve Implantation System
- Keywords
- Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Engager transcatheter aortic valve implantation system, Engager bioprosthesis
- 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 Transcatheter Aortic Valve Implantation SystemDevice
The Engager Transcatheter Aortic Valve Implantation System is indicated for use in patients with symptomatic severe aortic valve stenosis requiring aortic valve replacement and are at high or extreme risk for operative mortality or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement. The system is intended for use in patients with a life expectancy of at least one year following TAVI. The intended performance of the system is to provide relief of aortic valve obstruction without inducing significant regurgitation, thereby restoring effective hemodynamic function of the diseased aortic valve. The intended purpose of the system in this clinical study is in line with the intended purpose in the Instructions for Use.
What is being measured
The primary outcome is the main question the study is designed to answer.
is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.
The study objective is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.
The primary endpoint of this study is all-cause mortality at 30 days or during index hospitalization.
Measured: 12 months
Secondary outcomes (1)
Device success according to VARC2
Absence of procedural mortality (all-cause mortality at discharge, 30 days or during index hospitalization), AND correct positioning of the Engager bioprosthesis in the proper anatomic location, AND Engager bioprosthesis performing as intended (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe regurgitation).
Composite early safety (at 30 days) according to VARC2. All-cause mortality at 6 months and 1 year; Cardiovascular mortality at 30 days, 6 months and 1 year; Incidence of TAVI-related complications at 30 days, 6 months and 1 year
Measured: 12 Month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hendrik Treede, MD, Principal investigator, Universitätsklinikum Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149654
- Sponsor's protocol ID
- RAE00937
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2014
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Engager ALIGN Study. To Characterize the Safety and Clinical Benefit of the Engager Transcatheter Aortic Valve Implantation System in a Real World Environment.
- ClinicalTrials.gov ID
- NCT02149654
- Acronym / sponsor ID
- RAE00937
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Engager transcatheter aortic valve implantation system, Engager bioprosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market study.
250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1 month, 6 months, and 12 months after the procedure. The recruitment period will be approximately 12 months, so the total study duration will be 24 months.
Detailed description
The study objective is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.
The primary endpoint of this study is all-cause mortality at 30 days or during index hospitalization.
Secondary endpoints of this study are:
- Device success according to VARC2 is defined as:
- absence of procedural mortality (all-cause mortality at discharge, 30 days or during index hospitalization), AND
- correct positioning of the Engager bioprosthesis in the proper anatomic location, AND
- Engager bioprosthesis performing as intended (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe regurgitation).
- Composite early safety (at 30 days) according to VARC2 includes the following components:
- 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)
- Clinical efficacy according to VARC2 at 6 months and 1 year is defined as:
- all-cause mortality
- all stroke
- hospitalizations for valve-related symptoms or worsening congestive heart failure (CHF)
- NYHA class III or IV
- valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area (EOA) ≤0.9-1.1 cm² and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
- Time-related valve safety accordingly to VARC2 at 6 months and 1 year is defined as:
- Structural valve deterioration
- Valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, (EOA) ≤0.9-1.1 cm² and/or (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
- Requiring repeat procedure (TAVI or SAVR)
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thrombo-embolic events (e.g. stroke)
- VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)
- All-cause mortality at 6 months and 1 year
- Cardiovascular mortality at 30 days, 6 months and 1 year
- Incidence of TAVI-related complications at 30 days, 6 months and 1 year:
- Myocardial infarction
- Periprocedural and spontaneous stroke
- Life-threatening, major and minor bleedings
- Acute kidney injury state 1, 2 and 3
- Apical and vascular complications
- Conduction disturbances
- Conversion to open-heart surgery
- Unplanned use of cardiopulmonary bypass
- Coronary obstruction and dissection
- Ventricular septal perforation
- Mitral valve apparatus damage or dysfunction
- Cardiac tamponade
- Endocarditis
- Valve thrombus
- Valve migration, embolization or ectopic valve deployment
- Valve in valve deployment
- Total, transvalvular and paravalvular regurgitation as measured by TTE at 30 days and 1 year
- Mean aortic valve gradient, peak velocity and effective orifice area as measured by TTE at 30 days and 1 year
- Engager implant depth as measured by standard of care angiography at the end of implant procedure
- Incidence and rationale for permanent pacemaker implantation after Engager implant procedure
- Changes in Quality of Life as measured by the EQ5D questionnaire at baseline, discharge, 30 days, 6 months and 1 year
- Length of stay during index hospitalization (ICU and general ward)
- Incidence of re-hospitalization at 30 days, 6 months and 1 year
Subject population All patients with severe aortic stenosis requiring treatment, who are selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve Implantation System are eligible to be included in this study.
Treatment The Engager Transcatheter Aortic Bioprosthesis will be implanted using the Engager Transcatheter Delivery System. The bioprosthesis is delivered transapically on a catheter during a beating heart procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe aortic stenosis requiring treatment, who are selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve Implantation System are eligible to be included in this study.
Key inclusion criteria (5 listed)
- Patient with severe aortic valve stenosis requiring treatment;
- Patient is an acceptable candidate for elective treatment with the Medtronic Engager Transcatheter Aortic Valve Implantation System and in conformity with the local regulatory requirements;
- Patient is above the minimum age as required by local regulations to be participating in a clinical study;
- The patient has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form or Data Release Form).
Key exclusion criteria (11 listed)
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol of contrast medium that cannot be adequately controlled with pre-medication;
- Intracardiac mass, thrombus, or vegetation;
- Aortic aneurysm;
- Sepsis or acute endocarditis;
- Bleeding diathesis, or coagulopathy;
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 Transcatheter Aortic Valve Implantation SystemThe Engager Transcatheter Aortic Valve Implantation System is indicated for use in patients with symptomatic severe aortic valve stenosis requiring aortic valve replacement and are at high or extreme risk for operative mortality or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement. The system is intended for use in patients with a life expectancy of at least one year following TAVI. The intended performance of the system is to provide relief of aortic valve obstruction without inducing significant regurgitation, thereby restoring effective hemodynamic function of the diseased aortic valve. The intended purpose of the system in this clinical study is in line with the intended purpose in the Instructions for Use. | Device | – |
Primary outcome
is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.
Time frame: 12 months
The study objective is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting. The primary endpoint of this study is all-cause mortality at 30 days or during index hospitalization.
1 secondary outcome
Device success according to VARC2
Time frame: 12 Month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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
Universitätsklinikum Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.
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 5 inclusion and 11 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2018.