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OpenTrials
Completed

NCT Number: NCT03112629

Study to Improve Outcomes in Aortic Stenosis

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bichat Hospital Paris, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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)

  2. Outcomes (survival) (intervention vs. conservative treatment)

    Time frame: 12 months

    rates of death

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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