Improving Patient Reported Outcome Measures in Catheter Ablation

Not Applicable

Recruiting

• Conditions: Quality of Life; Ventricular Tachycardia; ICD
• Interventions: Other: Validated quality of life questionnaire (EQ-5D & C-CAP)

• Registration Number: NCT04499326
• Lead Sponsor: Barts & The London NHS Trust

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.

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.

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2024-06-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Adults (>18 years) With an Implantable Cardioverter Defibrillator (ICD) implanted >3 months from time of recruitment and a previous episode of documented VT requiring therapy from the ICD.

And impaired LV/RV function Willing and able to give written informed consent

Exclusion Criteria

Patients who are planning to move away from study site within 12 months of enrolment who wished to use postal method to complete their HRQL Patients who are unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Validated quality of life questionnaire (EQ-5D & C-CAP)	Patients undergoing AAD therapy for VT
Intervention	Validated quality of life questionnaire (EQ-5D & C-CAP)	Patients undergoing catheter ablation of VT

Primary Outcome Measures

Name	Time	Method
Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy	1 year follow up

Secondary Outcome Measures

Name	Time	Method
Recruitment rate of patients who fulfil study criteria	1 year
- Patient preferences for either paper or electronic HQRL (as a percentage of total recruitment)	1 year
Patient reported HRQL of VT ablation and AAD therapy on both EQ-5D and C-CAP	18 months
Impact on the cost-effectiveness calculation of VT ablation (using EQ-5D, and a number of different EQ-5D data points)	18 months	Using the Incremental Cost-effectiveness ratio

Trial Locations

Locations (1)

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom