Aortic Valve StenosisNCT04810195
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
An observational study of Aortic Valve Stenosis, run by Andreas Rück at 4 sites in 3 countries.
Trial summary
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Boston Scientific Acurate neo2 TAVR device
- Type of treatment
- Medical device
- How many people
- 554 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Sep 2020to 15 Mar 2022
- 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: The first 500 consecutive patients treated with the Acurate neo2 from up to 15 European sites which have started using the Acurate neo2.
Who may be able to join
- that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).
Who cannot join
- None
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Lund University Hospital
Lund
Karolinska University Hospital
Stockholm
About this study
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.
Read the detailed description
Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.
Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.
Karolinska will be the coordinating center for data collection.
Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).
Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).
Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Boston Scientific Acurate neo2 TAVR device
- Keywords
- TAVR
- 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.
Boston Scientific Acurate neo2 TAVR deviceDevice
The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
any of
- Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported)
- Postoperative new permanent pacemaker (in hospital)
- 30 days mortality
- 30 days stroke
- Acute Kidney Injury (AKIN grade 3) (in hospital)
Measured: 30 days
Secondary outcomes (5)
Rate of Postoperative aortic insufficiency more than mild by transthoracic echo
Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency
Measured: Within 7 days of procedure
Rate of Postoperative aortic insufficiency more than mild by aortography
Core-lab analysis of the aortogram in the end of the procedure for quantification of aortic insufficiency (videodensitometry): rate of patients with more than mild insuffiency
Measured: Same day as procedure
Postoperative aortic valve gradients
Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram
Measured: Within 7 days of procedure
Rate of major acute procedural complications
Intraprocedural complications such as valve embolization, need for second valve, anular rupture
Measured: Same day as procedure
Procedural contrast use
The average amount of contrast in ml per procedure
Measured: Same day as procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion15 Mar 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Rück
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Andreas Rück, Karolinska University Hospital
- Investigators
- Andreas Rück, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810195
- Sponsor's protocol ID
- HKN AR01
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
- ClinicalTrials.gov ID
- NCT04810195
- Acronym / sponsor ID
- HKN AR01
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Andreas RückUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- 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.
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.
Detailed description
Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.
Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.
Karolinska will be the coordinating center for data collection.
Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).
Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).
Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The first 500 consecutive patients treated with the Acurate neo2 from up to 15 European sites which have started using the Acurate neo2.
Key inclusion criteria (1 listed)
- that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Boston Scientific Acurate neo2 TAVR deviceThe newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020. | Device | – |
Primary outcome
MACE
Time frame: 30 days
any of * Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported) * Postoperative new permanent pacemaker (in hospital) * 30 days mortality * 30 days stroke * Acute Kidney Injury (AKIN grade 3) (in hospital)
5 secondary outcomes
Rate of Postoperative aortic insufficiency more than mild by transthoracic echo
Time frame: Within 7 days of procedure
Rate of Postoperative aortic insufficiency more than mild by aortography
Time frame: Same day as procedure
Postoperative aortic valve gradients
Time frame: Within 7 days of procedure
Rate of major acute procedural complications
Time frame: Same day as procedure
Procedural contrast use
Time frame: Same day as procedure
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 5 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, 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
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Andreas Rück, MD PhD principal investigator
Karolinska University Hospital
4 sites in 3 countries: 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 Andreas Rück at 4 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 1 inclusion and 1 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Denmark, Germany. 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?
MACE (time frame: 30 days). 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 5 Oct 2022.