Skip to main content
OpenTrials
Completed

NCT Number: NCT01672528

Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Birmingham Foundation Trust, Birmingham, United Kingdom

Loading trial locations.

About this study

This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research.

Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure.

The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with symptomatic cardiac arrhythmias
  • Consented to and awaiting a cardiac ablation procedure
  • Able to read, write and understand English or Welsh
  • Capable of giving informed written consent

Exclusion criteria

  • Not able to read, write and understand English or Welsh
  • Not able to provide informed written consent

Treatment and study plan

interview

Other

Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire

Other names: Disease specific questionnaire, EQ5D5L

questionnaires

Other

Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure

Other names: Disease specific questionnaire, EQ5D

Primary outcomes

  1. Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?

    Time frame: Up to 5 years post ablation

    This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.

Secondary outcomes

  1. Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?

    Time frame: Average 10 weeks post ablation

  2. Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?

    Time frame: Up to 5 years post-ablation.

  3. Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?

    Time frame: Average 10 weeks post ablation

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Collaborators

  • National Institute for Health and Clinical Excellence
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • University College, London
  • University Hospital Birmingham NHS Foundation Trust

Registry information

Official study title

A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2012
Registry last updated
Jan 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.