NCT04499326

Improving Patient Reported Outcome Measures in Catheter Ablation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 Bartholomew's 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.

Conditions

• Ventricular Tachycardia
• ICD
• Quality of Life

Interventions

Type	Name	Description
OTHER	Validated quality of life questionnaire (EQ-5D & C-CAP)	Patient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-08-05
• Last updated: 2026-03-02

Locations

1 site across 1 country: United Kingdom