Aortic Valve StenosisNCT03112629
Study to Improve Outcomes in Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 2 sites in 2 countries.
Trial summary
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 791 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Mar 2017to 3 Apr 2019
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).
Who may be able to join
- age over 18 years
- identified on echocardiography with severe aortic stenosis, defined as at least one of:
- aortic valve area < 1 cm2
- indexed valve area < 0.6 cm2/m2
- maximum jet velocity > 4.0 m/sec
- mean transvalvular gradient > 40 mmHg
Who cannot join
- non-severe aortic stenosis
- previous aortic valve repair
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Department of Cardiology and Angiology, University of Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions).
The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.
Read the detailed description
Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access.
The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.
- Conditions
- Aortic Valve Stenosis
- Keywords
- Quality of Care, aortic stenosis, transcatheter aortic valve implantation, surgical aortic valve replacement, facilitated data relay
- 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.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic AS | Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope. | |
| asymptomatic AS | Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals
The purpose of this study is to determine treatment pathways for patients with severe AS and to find out about the critical steps in this pathway with respect to the time-course and treatment decisions made.
Measured: 12 months
Secondary outcomes (2)
Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)
Time course for the transition from asymptomatic in symptomatic severe AS and analysis of multivariables predictors for the development of symptoms (based on echo data and comorbidities at baseline)
Measured: 12 months
Outcomes (survival) (intervention vs. conservative treatment)
rates of death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start23 Mar 2017
- Primary completion12 Mar 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 791 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Stephan Balduss, Prof, Study chair, University of CologneNorbert Frey, Prof, Study chair, University of Kiel, GermanyRichard Steeds, Prof, Study chair, Queen Elizabeth Hospital, Birmingham, UKDavid Messika-Zeitoun, Prof, Study chair, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112629
- Sponsor's protocol ID
- Impulse enhanced
- Status last verified
- Feb 2020
- First submitted
- 21 Mar 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing of individual patient data is planned
Publications
Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Steeds RP; IMPULSE enhanced investigators. Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres. Heart. 2023 May 26;109(12):944-950. doi: 10.1136/heartjnl-2022-321566.
PubMed 36657962Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.
PubMed 31413844
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03112629
- Acronym / sponsor ID
- Impulse enhanced
- Conditions
- Aortic Valve Stenosis
- Keywords
- Quality of Care, aortic stenosis, transcatheter aortic valve implantation, surgical aortic valve replacement, facilitated data relay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 791 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 13 Apr 2017 (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.
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions).
The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.
Detailed description
Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access.
The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic AS | – | –Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope. |
| asymptomatic AS | – | –Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).
Key inclusion criteria (6 listed)
- age over 18 years
- identified on echocardiography with severe aortic stenosis, defined as at least one of:
- aortic valve area < 1 cm2
- indexed valve area < 0.6 cm2/m2
- maximum jet velocity > 4.0 m/sec
Key exclusion criteria (2 listed)
- non-severe aortic stenosis
- previous aortic valve repair
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
Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals
Time frame: 12 months
The purpose of this study is to determine treatment pathways for patients with severe AS and to find out about the critical steps in this pathway with respect to the time-course and treatment decisions made.
2 secondary outcomes
Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)
Time frame: 12 months
Outcomes (survival) (intervention vs. conservative treatment)
Time frame: 12 months
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 26 Feb 2020.
- Derived from this study: PubMed 36657962Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Steeds RP; IMPULSE enhanced investigators. Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres. Heart. 2023 May 26;109(12):944-950. doi: 10.1136/heartjnl-2022-321566.
- Derived from this study: PubMed 31413844Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.
- Individual participant dataSharing planned: No. no sharing of individual patient data is planned
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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.
Stephan Balduss, Prof study chair
University of Cologne
Norbert Frey, Prof study chair
University of Kiel, Germany
Richard Steeds, Prof study chair
Queen Elizabeth Hospital, Birmingham, UK
2 sites in 2 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 Institut für Pharmakologie und Präventive Medizin at 2 sites in 2 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 2 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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?
Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals (time frame: 12 months). 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 NCT03112629, which also lists 2 linked publications.
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 Feb 2020.