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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Ventricular Tachycardia; ICD
• Intervention / Treatment: Other: Validated quality of life questionnaire (EQ-5D & C-CAP)

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Patients undergoing catheter ablation of VT	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
ACTIVE_COMPARATOR: Comparator; Patients undergoing AAD therapy for VT	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Using the Incremental Cost-effectiveness ratio	18 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: University College, London

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2023
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (ACTUAL): August 5, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Catheter ablation; Patient reported outcome measure; Incremental cost effectiveness ratio
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: IRAS 264743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for outcome measures will be made available
• IPD Sharing Time Frame: In accordance with NHS Research governance framework
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No