Improving Patient Reported Outcome Measures in Catheter Ablation

February 26, 2026 updated by: Barts & The London NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • St Bartholomew'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy
Time Frame: 1 year follow up
1 year follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recruitment rate of patients who fulfil study criteria
Time Frame: 1 year
1 year
- Patient preferences for either paper or electronic HQRL (as a percentage of total recruitment)
Time Frame: 1 year
1 year
Patient reported HRQL of VT ablation and AAD therapy on both EQ-5D and C-CAP
Time Frame: 18 months
18 months
Impact on the cost-effectiveness calculation of VT ablation (using EQ-5D, and a number of different EQ-5D data points)
Time Frame: 18 months
Using the Incremental Cost-effectiveness ratio
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barts & The London NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pier Lambiase, PhD, UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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