Study to Improve Outcomes in Aortic Stenosis

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 791

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bichat Hospital Paris
• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Department of Cardiology and Angiology, University of Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
symptomatic AS; Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope.
asymptomatic AS; Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Outcomes (survival) (intervention vs. conservative treatment)	rates of death	12 months

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborators: Edwards Lifesciences
• Investigators: Study Chair: Stephan Balduss, Prof, University of Cologne; Study Chair: Norbert Frey, Prof, University of Kiel, Germany; Study Chair: Richard Steeds, Prof, Queen Elizabeth Hospital, Birmingham, UK; Study Chair: David Messika-Zeitoun, Prof, Bichat Hospital, Paris, France

Publications and helpful links

General Publications

• Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): March 12, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: aortic stenosis; transcatheter aortic valve implantation; surgical aortic valve replacement; Quality of Care; facilitated data relay
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: Impulse enhanced

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no sharing of individual patient data is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No