Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01672528
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2012-08-16
Brief Title:
Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias
Sponsor:
Cardiff and Vale University Health Board
Organization:
Cardiff and Vale University Health Board
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6125 | OTHER | Newcastle RD | None |
| RRK 4429 | OTHER | None | None |