Study to Improve Outcomes in Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:

IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112629
• Other study ID #: Impulse enhanced
• Status: Completed
• Start date: March 23, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: February 2020
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 791
• Est. completion date: April 3, 2019
• Est. primary completion date: March 12, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• non-severe aortic stenosis

• previous aortic valve repair

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
France	Bichat Hospital Paris	Paris
Germany	Department of Cardiology and Angiology, University of Kiel	Kiel	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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)	12 months
Secondary	Outcomes (survival) (intervention vs. conservative treatment)	rates of death	12 months