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NCT02241447 Clinical Trial

Quality of Care in AS IMPULSE Study

Aortic Valve Stenosis Clinical Trial

— IMPULSE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02241447
Other study ID # IMPULSE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2014
Est. completion date May 31, 2018

Study information
Verified date March 2020
Source Institut für Pharmakologie und Präventive Medizin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 2173
Est. completion date May 31, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Krankenhaus Hietzing Wien
Czechia IKEM - Institute for Clinical and Experimental Medicine Prag
France Centre Hospitalier d'Annecy Annecy
France Bichat Hospital Paris
Germany Charité - Campus Benjamin Franklin Berlin
Germany Universitätsklinikum Erlangen Erlangen
Germany Westpfalz Klinikum Kaiserslautern
Germany UKSK Campus Kiel, Klinik für Kardiologie und Angiologie Kiel
Germany Herzzentrum Universitätsklinikum Köln Köln
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Germany Städtisches Klinikum München München
Germany Krankenhaus der Barmherzigen Brüder Trier
Italy Università degli Studi di Bari Aldo Moro Bari
Italy University "Magna Græcia" of Catanzaro Catanzaro
Italy IRCCS San Matteo Hospital Pavia
Italy Policlinico Umberto I Rom Rom
Italy University of Torino Torino
Netherlands AMC Medical Center Amsterdam
Spain Santa Creu Barcelona Barcelona
Switzerland UniversitätsSpital Zürich Zürich
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom Bart Heart Center London
United Kingdom James Cook University Hospital Middlesbrough

Sponsors (2)
Lead Sponsor Collaborator
Institut für Pharmakologie und Präventive Medizin Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Czechia,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Referral rates at 3 months for Intervention (SAVR or TAVI) 3 months
Secondary Referral rates at 3 months for exercise testing or stress echocardiography 3 months
Secondary Time to next out-patient appointment or clinical review 15 months
Secondary Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment) 3 months
Secondary Appropriateness of treatment decisions made in collaboration with the valve specialist 3 months
Secondary Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment 3 months
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Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
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Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease

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