Aortic Valve DiseaseMISSIONNCT02907463
EDWARDS INTUITY Elite Valve System
An observational study of Aortic Valve Disease and Aortic Stenosis, run by Edwards Lifesciences at 23 sites in 9 countries.
Trial summary
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Stenosis
- How many people
- 280 participants
- Where
- 23 sitesin 9 countries
- Study dates
- Feb 2016to Dec 2017
- Phase
- Observational
- 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
Study population: * Adult subjects, age18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency requiring isolated aortic valve replacement (AVR) * Subjects whose medical records indicate they are a suitable candidate for Minimally Invasive Surgery (MIS) * Subjects whose treating physician is the Principle Investigator or a Sub-Investigator participating in the study and has been trained on the EDWARDS INTUITY Elite Valve System * Subject shall be drawn from the general patient population served by each investigational center * Candidates for this study must meet all of the following Inclusion criteria and none of the Exclusion criteria or intra-op exclusion criteria
Who may be able to join
- Subject is 18 years or older
- Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
- Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
- Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
- Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
- Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Who cannot join
- Subject is diagnosed with pure aortic insufficiency.
- Subject requires multiple valve replacement/repair
- Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
- Subject has severe ventricular dysfunction defined as LVEF < 25%.
- Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
- Subject has had an acute MI ≤ 3 months before the intended treatment.
Show all 24Show fewer
- Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
- Subject is oxygen or ventilator dependent.
- Subject has life expectancy < 12 months.
- Female subject is pregnant or lactating.
- Subject with documented leukopenia (WBC < 3.5x 103/μL), anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.
- Subject has renal insufficiency as determined by Serum creatinine
- ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
- Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
- Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
- Aneurysm of the aortic root and/or ascending aorta
- Intra-operative exclusion criteria:
- Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
- Subject has calcium on the anterior mitral leaflet which cannot be removed.
- Subject has extensive calcification of the aortic root.
- Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
- The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
- Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
- The device is not available in the correct size for the subject.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Germany6 sites
Herz- und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, 97616
Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie
Bochum, 44789
Herzzentrum Uniklinik Köln
Cologne, 50924
Medizinische Hochschule Hannover
Hanover, 30625
Herzzentrum Leipzig
Leipzig, 04289
University Hospital Würzburg
Würzburg, 97080
Italy5 sites
G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation
Massa, 54100
CentroCardiologico Monzino
Milan, 20138
Clinica San Gaudenzio
Novara
Università Cattolica del Sacro Cuore Policlinico
Roma, 00168
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"
Udine, 33100
Spain3 sites
Complexo Hospitalario Universitario A Coruna
A Coruña
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Clínico San Carlos
Madrid, 28040
Austria2 sites
Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck
Innsbruck, 6020
Klinisshe Abteiluing Für Herz-thoraxchirurgie
Vienna, 1090
France2 sites
CHU Bocage Central Dijon
Dijon, 21074
Hôpital Cardiologique CHU Bordeaux Haut Leveque
Pessac, 33 604
United Kingdom2 sites
Royal Infirmary Hospital Edinburgh
Edinburgh, EH16 4SA
St Thomas' Hospital
London, SE1 7EH
Luxembourg1 site
Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)
Luxembourg, 1210
About this study
Official title: Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.
Read the detailed description
Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.
Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.
Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.
In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Elite Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.
The system includes the EDWARDS INTUITY Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.
With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Elite Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY Elite, Rapid deployment valves
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Average Time Spent on Cardiopulmonary Cross Clamp
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Measured: At time of surgery; an average of 1 hour
Secondary outcomes (14)
Subject's Average Time Spent on Cardiopulmonary Bypass.
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Measured: At time of surgery; an average of 1.5 hours
Device Technical Success Rate
The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.
Measured: At time of surgery
First Attempt Success Rate
The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.
Measured: At time of surgery
Procedural Success
Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.
Measured: Day of procedure and events occurring within 10 days of procedure
Subject's Average Health Care Utilization
The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.
Measured: Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.
Subject's Average Mean Gradient Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Measured: Baseline, Discharge and 6 months
Subject's Average Peak Gradients Measurements Over Time.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Measured: Baseline, Discharge and 6 months
Subject's Average Effective Orifice Area (EOA) Measurements Over Time
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Measured: Baseline, Discharge and 6 months
Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Measured: Discharge and 6 months
Subject's Average Performance Index Measurements Over Time.
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.
Measured: Baseline, Discharge and 6 months
Subject's Average Cardiac Output Over Time
The amount of blood the heart pumps through the circulatory system in a minute.
Measured: Baseline, Discharge and 6 months
Subject's Average Cardiac Index
A measure of cardiac output per square meter of body surface area
Measured: Discharge and 6 months
Subject's Amount of Paravalvular Leak Over Time.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Measured: Discharge and 6 months
Subject's Amount of Aortic Valvular Regurgitation Over Time.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Measured: Discharge and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionDec 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Young, MD FRCS, Principal investigator, St. Thomas' HospitalGunther Laufer, Prof. Dr. med, Principal investigator, AKH Vienna Dep. of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907463
- Sponsor's protocol ID
- 2015-05
- Acronym
- MISSION
- Status last verified
- Nov 2019
- First submitted
- 29 Jun 2016
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Laufer G, Strauch JT, Terp KA, Salinas M, Arribas JM, Massetti M, Andreas M, Young CP. Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system. Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2):ivac083. doi: 10.1093/icvts/ivac083.
PubMed 35394527
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry
- ClinicalTrials.gov ID
- NCT02907463
- Acronym / sponsor ID
- MISSION / 2015-05
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY Elite, Rapid deployment valves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.
Detailed description
Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.
Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.
Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.
In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Elite Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.
The system includes the EDWARDS INTUITY Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.
With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Elite Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Adult subjects, age18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency requiring isolated aortic valve replacement (AVR) * Subjects whose medical records indicate they are a suitable candidate for Minimally Invasive Surgery (MIS) * Subjects whose treating physician is the Principle Investigator or a Sub-Investigator participating in the study and has been trained on the EDWARDS INTUITY Elite Valve System * Subject shall be drawn from the general patient population served by each investigational center * Candidates for this study must meet all of the following Inclusion criteria and none of the Exclusion criteria or intra-op exclusion criteria
Key inclusion criteria (6 listed)
- Subject is 18 years or older
- Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
- Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
- Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
- Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
Key exclusion criteria (24 listed)
- Subject is diagnosed with pure aortic insufficiency.
- Subject requires multiple valve replacement/repair
- Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
- Subject has severe ventricular dysfunction defined as LVEF < 25%.
- Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subject's Average Time Spent on Cardiopulmonary Cross Clamp
Time frame: At time of surgery; an average of 1 hour
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
14 secondary outcomes
Subject's Average Time Spent on Cardiopulmonary Bypass.
Time frame: At time of surgery; an average of 1.5 hours
Device Technical Success Rate
Time frame: At time of surgery
First Attempt Success Rate
Time frame: At time of surgery
Procedural Success
Time frame: Day of procedure and events occurring within 10 days of procedure
Subject's Average Health Care Utilization
Time frame: Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.
Subject's Average Mean Gradient Measurements Over Time.
Time frame: Baseline, Discharge and 6 months
Subject's Average Peak Gradients Measurements Over Time.
Time frame: Baseline, Discharge and 6 months
Subject's Average Effective Orifice Area (EOA) Measurements Over Time
Time frame: Baseline, Discharge and 6 months
Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.
Time frame: Discharge and 6 months
Subject's Average Performance Index Measurements Over Time.
Time frame: Baseline, Discharge and 6 months
Subject's Average Cardiac Output Over Time
Time frame: Baseline, Discharge and 6 months
Subject's Average Cardiac Index
Time frame: Discharge and 6 months
Subject's Amount of Paravalvular Leak Over Time.
Time frame: Discharge and 6 months
Subject's Amount of Aortic Valvular Regurgitation Over Time.
Time frame: Discharge and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35394527Laufer G, Strauch JT, Terp KA, Salinas M, Arribas JM, Massetti M, Andreas M, Young CP. Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system. Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2):ivac083. doi: 10.1093/icvts/ivac083.
- The Optum (SF-26v2) Health Survey questions to measure functional health and well-being from the patient's point of viewLink provided by the sponsor.
Related trials for Aortic Valve Disease
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
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)
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.
Christopher Young, MD FRCS principal investigator
St. Thomas' Hospital
Gunther Laufer, Prof. Dr. med principal investigator
AKH Vienna Dep. of Cardiovascular Surgery
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Aortic Stenosis, run by Edwards Lifesciences at 23 sites in 9 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 24 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Italy, Spain, Austria, France and 4 more countries. 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 8 Nov 2019). 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?
Subject's Average Time Spent on Cardiopulmonary Cross Clamp (time frame: At time of surgery; an average of 1 hour). 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 NCT02907463, which also lists 1 linked publication.
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 22 Nov 2019.