Study to Improve Outcomes in Aortic Stenosis

• ClinicalTrials.gov Identifier: NCT03112629
• Recruitment Status: Completed
• First Posted: April 13, 2017
• Last Update Posted: February 26, 2020
• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborator: Edwards Lifesciences
• Information provided by (Responsible Party): Institut für Pharmakologie und Präventive Medizin

Tracking Information

• First Submitted Date: March 21, 2017
• First Posted Date: April 13, 2017
• Last Update Posted Date: February 26, 2020
• Actual Study Start Date: March 23, 2017
• Actual Primary Completion Date: March 12, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2017)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2017)

• 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)
• Outcomes (survival) (intervention vs. conservative treatment) [ Time Frame: 12 months ]
  rates of death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Improve Outcomes in Aortic Stenosis
• Official Title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study

Brief 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.

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 [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).
• Condition: Aortic Valve Stenosis
• Intervention: Not Provided

Study Groups/Cohorts

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2019): 791
• Original Estimated Enrollment (submitted: April 7, 2017): 800
• Actual Study Completion Date: April 3, 2019
• Actual Primary Completion Date: March 12, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany

Administrative Information

• NCT Number: NCT03112629
• Other Study ID Numbers: Impulse enhanced
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: no sharing of individual patient data is planned

• Current Responsible Party: Institut für Pharmakologie und Präventive Medizin
• Original Responsible Party: Same as current
• Current Study Sponsor: Institut für Pharmakologie und Präventive Medizin
• Original Study Sponsor: Same as current
• 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

• PRS Account: Institut für Pharmakologie und Präventive Medizin
• Verification Date: February 2020