Aortic Valve StenosisBAVNCT04053192
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
An observational study of Aortic Valve Stenosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis. Read more about this study
- Who is it for?
- Ages 50 to 97 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- BAV, BAV + TAVR and SAVR
- Type of treatment
- Surgery or procedure
- How many people
- 166 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 31 Aug 2019
- 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 50 to 97 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the heart failure program of the University of Duesseldorf
Who may be able to join
- Patients with Severe Aortic Stenosos who underwent BAV
Who cannot join
- insufficient echocardiographic parameters before BAV
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
Read the detailed description
The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.
Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.
The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.
- Conditions
- Aortic Valve Stenosis
- Being tested
- BAV, BAV + TAVR, SAVR
- Keywords
- Balloon Aortic Valvuloplasty, Severe Aortic Valve Stenosis, Surgical aortic valve replacement (SAVR)
- 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.
BAVProcedure or surgery
BAV
BAV + TAVRProcedure or surgery
BAV + TAVR
SAVRProcedure or surgery
Surgical aortic valve replacement (SAVR)
| Study group | Role | What they receive |
|---|---|---|
| High-Gradient Aortic Stenosis (HG-AS) | (Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s) Receives: Procedure: BAV; Procedure: BAV + TAVR; Procedure: SAVR | |
| Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) | (Pmean <40mmHg, AVA <1cm^2, Vmax <4m/s, EF <50%) Receives: Procedure: BAV; Procedure: BAV + TAVR; Procedure: SAVR | |
| Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) | Pmean <40mmHg, AVA <1cm^2, Vmax < 4m/s, EF >50%) Receives: Procedure: BAV; Procedure: BAV + TAVR; Procedure: SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
Measured: 1-Year post BAV
Post-Procedure Hemodynamic Changes
dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
Measured: 24 - 72 h after procedure
Secondary outcomes (5)
Number of patients with myocardial infarction
Evaluation by using the VARC-2 definition
Measured: 30 days after intervention
Number of patients with stroke
Evaluation by using the VARC-2 definition
Measured: 30 days after intervention
Number of patients with bleeding complications
Evaluation by using the VARC-2 definition
Measured: 30 days after intervention
Number of patients with acute kidney injury
Evaluation by using the VARC-2 definition
Measured: 30 days after intervention
Number of patients with vascular complications
Evaluation by using the VARC-2 definition
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Jun 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Zeus, MD, Principal investigator, Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053192
- Sponsor's protocol ID
- 19-003 BAV
- Acronym
- BAV
- Status last verified
- Nov 2022
- First submitted
- 7 Aug 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT04053192
- Acronym / sponsor ID
- BAV / 19-003 BAV
- Conditions
- Aortic Valve Stenosis
- Keywords
- Balloon Aortic Valvuloplasty, Severe Aortic Valve Stenosis, Surgical aortic valve replacement (SAVR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 12 Aug 2019 (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 purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
Detailed description
The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.
Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease.
The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Gradient Aortic Stenosis (HG-AS) | – | Procedure: BAV, Procedure: BAV + TAVR, Procedure: SAVR(Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s) |
| Low-Flow-Low-Gradient Aortic Stenosis (LF-LG) | – | Procedure: BAV, Procedure: BAV + TAVR, Procedure: SAVR(Pmean <40mmHg, AVA <1cm^2, Vmax <4m/s, EF <50%) |
| Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) | – | Procedure: BAV, Procedure: BAV + TAVR, Procedure: SAVRPmean <40mmHg, AVA <1cm^2, Vmax < 4m/s, EF >50%) |
Who may qualify
- Ages
- 50 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the heart failure program of the University of Duesseldorf
Key inclusion criteria (1 listed)
- Patients with Severe Aortic Stenosos who underwent BAV
Key exclusion criteria (1 listed)
- insufficient echocardiographic parameters before BAV
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 |
|---|---|---|
| BAVBAV | Procedure or surgery | High-Gradient Aortic Stenosis (HG-AS), Low-Flow-Low-Gradient Aortic Stenosis (LF-LG), Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) |
| BAV + TAVRBAV + TAVR | Procedure or surgery | High-Gradient Aortic Stenosis (HG-AS), Low-Flow-Low-Gradient Aortic Stenosis (LF-LG), Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) |
| SAVRSurgical aortic valve replacement (SAVR) | Procedure or surgery | High-Gradient Aortic Stenosis (HG-AS), Low-Flow-Low-Gradient Aortic Stenosis (LF-LG), Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS) |
Primary outcome
All-cause Mortality
Time frame: 1-Year post BAV
Post-Procedure Hemodynamic Changes
Time frame: 24 - 72 h after procedure
dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
5 secondary outcomes
Number of patients with myocardial infarction
Time frame: 30 days after intervention
Number of patients with stroke
Time frame: 30 days after intervention
Number of patients with bleeding complications
Time frame: 30 days after intervention
Number of patients with acute kidney injury
Time frame: 30 days after intervention
Number of patients with vascular complications
Time frame: 30 days after intervention
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 7 Nov 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.
Tobias Zeus, MD principal investigator
Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
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 Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 7 Nov 2022. 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 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?
All-cause Mortality (time frame: 1-Year post BAV). The study lists 2 primary outcomes in all. 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 7 Nov 2022.