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Comparison of Aortic Stenosis Subtypes After Balloon Aortic Valvuloplasty (BAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053192
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: BAV Procedure: BAV + TAVR

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Safety and Effectiveness of Aortic Stenosis Subtypes After Balloon Aortic Valvuloplasty as a Bridge Therapy
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High-Gradient Aortic Stenosis (HG-AS)
(Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s)
Procedure: BAV
BAV

Procedure: BAV + TAVR
BAV + TAVR

Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)
(Pmean <40mmHg, AVA <1cm^2, Vmax <4m/s, EF <50%)
Procedure: BAV
BAV

Procedure: BAV + TAVR
BAV + TAVR

Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)
Pmean <40mmHg, AVA <1cm^2, Vmax < 4m/s, EF >50%)
Procedure: BAV
BAV

Procedure: BAV + TAVR
BAV + TAVR




Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: 1-Year post BAV ]
  2. 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


Secondary Outcome Measures :
  1. Number of patients with myocardial infarction [ Time Frame: 30 days after intervention ]
    Evaluation by using the VARC-2 definition

  2. Number of patients with stroke [ Time Frame: 30 days after intervention ]
    Evaluation by using the VARC-2 definition

  3. Number of patients with bleeding complications [ Time Frame: 30 days after intervention ]
    Evaluation by using the VARC-2 definition

  4. Number of patients with acute kidney injury [ Time Frame: 30 days after intervention ]
    Evaluation by using the VARC-2 definition

  5. Number of patients with vascular complications [ Time Frame: 30 days after intervention ]
    Evaluation by using the VARC-2 definition



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 97 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the heart failure program of the University of Duesseldorf
Criteria

Inclusion Criteria:

  • Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria:

  • insufficient echocardiographic parameters before BAV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053192


Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Dusseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Tobias Zeus, MD Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principle Investigator PD Dr. Zeus, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT04053192     History of Changes
Other Study ID Numbers: 19-003 BAV
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
Balloon Aortic Valvuloplasty
Severe Aortic Valve Stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction