Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499326
Status:
RECRUITING
Last Update Posted:
2023-02-14
First Post:
2020-07-31
Brief Title:
Improving Patient Reported Outcome Measures in Catheter Ablation
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
Use of Patient Reported Outcome Measures PROMs to Assess Quality of Life and Economic Evaluation of Cardiac Catheter Ablation of Ventricular Tachycardia a Feasibility and Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This study will assess whether more frequent measurement of patient reported outcome measures PROMs - specifically health related quality of life HRQL - can improve the evaluation of the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular tachycardia VT in patients with an Implantable Cardioverter Defibrillator ICD
It is designed to have feasibility outcomes which contribute to answering the above
It is designed to have feasibility outcomes which contribute to answering the above
Detailed Description:
Patients who have been implanted with an ICD are at risk of suffering from dangerous arrhythmias such as VT
Patients can experience clinical events including worsening of any underlying heart failure regardless of either VT ablation or medical therapy treatment strategy anti-arrhythmic drugs AAD VT ablation is a specialist procedure which has been proven in randomised clinical trials RCTs to confer symptomatic relief from VT reduced hospitalisations and reduced shocks from ICDs However there is no effect on mortality
The frequent nature of clinical events in this group of patients may affect their health status quite dramatically and yet based on current trial evidence only 3 out of 6 randomised trials in VT ablation reported PROMs This can lead to brittle conclusions about the overall cost-effectiveness profile of a procedure such as VT ablation
This study will assess for the feasibility of more frequent HRQL monitoring and its impact on whether it is able to better capture the clinical narrative and quality of life changes of patients with severe heart failure and an ICD And thus the assessment of both clinical effectiveness and cost effectiveness of catheter ablation of VT or continuing anti arrhythmic drug therapy
METHOD SETTING Single centre study at St Bartholomews Hospital London Patients will be identified through established local pathways - there are traditional outpatient specialist clinics where Consultant Cardiologists receive referrals of patients for consideration of managing patients with VT including ablation In addition there are joint VT clinics operated by Consultants as well as by cardiac physiologists In the outpatient VT clinic 85 patients were seen in a 10-month window - it is assumed that this scale will allow feasible identification of patients to be recruited to the both the groups of this study
Patients can experience clinical events including worsening of any underlying heart failure regardless of either VT ablation or medical therapy treatment strategy anti-arrhythmic drugs AAD VT ablation is a specialist procedure which has been proven in randomised clinical trials RCTs to confer symptomatic relief from VT reduced hospitalisations and reduced shocks from ICDs However there is no effect on mortality
The frequent nature of clinical events in this group of patients may affect their health status quite dramatically and yet based on current trial evidence only 3 out of 6 randomised trials in VT ablation reported PROMs This can lead to brittle conclusions about the overall cost-effectiveness profile of a procedure such as VT ablation
This study will assess for the feasibility of more frequent HRQL monitoring and its impact on whether it is able to better capture the clinical narrative and quality of life changes of patients with severe heart failure and an ICD And thus the assessment of both clinical effectiveness and cost effectiveness of catheter ablation of VT or continuing anti arrhythmic drug therapy
METHOD SETTING Single centre study at St Bartholomews Hospital London Patients will be identified through established local pathways - there are traditional outpatient specialist clinics where Consultant Cardiologists receive referrals of patients for consideration of managing patients with VT including ablation In addition there are joint VT clinics operated by Consultants as well as by cardiac physiologists In the outpatient VT clinic 85 patients were seen in a 10-month window - it is assumed that this scale will allow feasible identification of patients to be recruited to the both the groups of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None