NCT04053192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

August 7, 2019

Last Update Submit

November 4, 2022

Conditions

Aortic Valve Stenosis

Keywords

Balloon Aortic ValvuloplastySevere Aortic Valve StenosisSurgical aortic valve replacement (SAVR)

Outcome Measures

Primary Outcomes (2)

  • All-cause Mortality

    1-Year post BAV

  • Post-Procedure Hemodynamic Changes

    dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR

    24 - 72 h after procedure

Secondary Outcomes (5)

  • Number of patients with myocardial infarction

    30 days after intervention

  • Number of patients with stroke

    30 days after intervention

  • Number of patients with bleeding complications

    30 days after intervention

  • Number of patients with acute kidney injury

    30 days after intervention

  • Number of patients with vascular complications

    30 days after intervention

Study Arms (3)

High-Gradient Aortic Stenosis (HG-AS)

(Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s)

Procedure: BAVProcedure: BAV + TAVRProcedure: SAVR

Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)

(Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%)

Procedure: BAVProcedure: BAV + TAVRProcedure: SAVR

Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)

Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%)

Procedure: BAVProcedure: BAV + TAVRProcedure: SAVR

Interventions

BAVPROCEDURE

BAV

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 + TAVRPROCEDURE

BAV + TAVR

High-Gradient Aortic Stenosis (HG-AS)Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)
SAVRPROCEDURE

Surgical aortic valve replacement (SAVR)

High-Gradient Aortic Stenosis (HG-AS)Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)

Eligibility Criteria

Age50 Years - 97 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the heart failure program of the University of Duesseldorf

You may qualify if:

  • Patients with Severe Aortic Stenosos who underwent BAV

You may not qualify if:

  • insufficient echocardiographic parameters before BAV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Tobias Zeus, MD

    Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 12, 2019

Study Start

June 1, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

DE(1)