Quality of Care in AS IMPULSE Study (IMPULSE)

Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis

Detailed Description

All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome.

Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.

Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented.

Observation B: Same as Observation Phase A

• Study Type: Observational
• Enrollment (Actual): 2173

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1130
    • Krankenhaus Hietzing
• Czechia
  • Prag, Czechia, 140 21
    • IKEM - Institute for Clinical and Experimental Medicine
• France
  • Annecy, France, 74374
    • Centre Hospitalier d'Annecy
  • Paris, France, 75018
    • Bichat Hospital
• Germany
  • Berlin, Germany, 10233
    • Charite - Campus Benjamin Franklin
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Kaiserslautern, Germany, 67655
    • Westpfalz Klinikum
  • Kiel, Germany, 24105
    • UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
  • Köln, Germany, 50924
    • Herzzentrum Universitätsklinikum Köln
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • München, Germany, 80337
    • Städtisches Klinikum München
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brüder
• Italy
  • Bari, Italy, 70121
    • Università degli studi di Bari Aldo Moro
  • Catanzaro, Italy, 88100
    • University "Magna Græcia" of Catanzaro
  • Pavia, Italy, 27100
    • IRCCS San Matteo Hospital
  • Rom, Italy, 00161
    • Policlinico Umberto I Rom
  • Torino, Italy
    • University of Torino
• Netherlands
  • Amsterdam, Netherlands, 1105
    • AMC Medical Center
• Spain
  • Barcelona, Spain, 08025
    • Santa Creu Barcelona
• Switzerland
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • London, United Kingdom, E1 1BB
    • Bart Heart Center
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults aged over 18years identified on echocardiography with severe AS

Description

Inclusion Criteria:

• Aortic valve area < 1cm2
• Indexed aortic valve area <0.6 cm/m2
• Maximum Jet velocity > 4.0 m/sec
• Mean transvalvular gradient > 40 mmHg

Exclusion Criteria:

• Non-severe aortic Stenosis (AS)
• Previous aortic valve replacement (AVR)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Observation; the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on
Early information; in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Referral rates at 3 months for Intervention (SAVR or TAVI)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Referral rates at 3 months for exercise testing or stress echocardiography	3 months
Time to next out-patient appointment or clinical review	15 months
Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)	3 months
Appropriateness of treatment decisions made in collaboration with the valve specialist	3 months
Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment	3 months

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Richard Steeds, MD, Queen Elizabeth Hospital, Birmingham, UK; Principal Investigator: Norbert Frey, MD, Department of Cardiology and Angiology, University of Kiel, Germany; Principal Investigator: Davia Messika-Zeitoun, MD, Hôpital Bichat, Paris FR

Publications and helpful links

General Publications

• Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.
• Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2014
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; Echo; SAVR; referral; aortic valve Stenosis
• 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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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