Improving Patient Reported Outcome Measures in Catheter Ablation

NCT04499326 | Recruiting

• 1 other identifier: IRAS 264743
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; ICD; Quality of Life

Keywords

Catheter ablation; Patient reported outcome measure; Incremental cost effectiveness ratio

Outcome Measures

Primary Outcomes (1)

• Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy

  1 year follow up

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Patients undergoing catheter ablation of VT

Other: Validated quality of life questionnaire (EQ-5D & C-CAP)

Comparator

ACTIVE COMPARATOR

Patients undergoing AAD therapy for VT

Other: Validated quality of life questionnaire (EQ-5D & C-CAP)

Interventions

Validated quality of life questionnaire (EQ-5D & C-CAP) OTHER

Patient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months

Comparator; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• University College, London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pier Lambiase, PhD

  UCL

  STUDY CHAIR

Central Study Contacts

Yang Chen, BM BCh

CONTACT

02034165000; yang.chen@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: June 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: In accordance with NHS Research governance framework
• Access Criteria: Upon reasonable request

Locations

GB (1)