Actively Recruiting
Use of Patient Reported Outcome Measures to Assess Quality of Life and Economic Evaluation of Cardiac Catheter Ablation of Ventricular Tachycardia: a Feasibility and Cohort Study
Led by Barts & The London NHS Trust · Updated on 2026-03-02
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Barts & The London NHS Trust
Lead Sponsor
U
University College, London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether more frequent collection of patient reported outcome measures, especially health related quality of life (HRQL), can improve how well the clinical and cost effectiveness of catheter ablation for ventricular tachycardia (VT) is understood. This study focuses on patients with an Implantable Cardioverter Defibrillator (ICD) who are at risk of dangerous heart rhythm problems. It aims to assess the feasibility of this monitoring approach to better capture changes in patients' quality of life and clinical status. The study compares two groups: patients undergoing catheter ablation of VT and those receiving anti-arrhythmic drug (AAD) therapy. Participants will complete validated quality of life questionnaires (EQ-5D and C-CAP) at baseline and at multiple time points over one year. The study takes place at a single center where patients are identified through outpatient VT clinics. This approach allows monitoring of quality of life changes more frequently than in previous trials. Participants will be followed for one year with repeated HRQL assessments at 1, 2, 3, 4, 6, 9, and 12 months. Researchers will track completion rates of these forms, recruitment rates, patient preferences for paper or electronic questionnaires, and HRQL outcomes. They will also evaluate the impact of this data on cost-effectiveness calculations for VT ablation. The study focuses on feasibility and improving the understanding of patient experiences with these treatments.
CONDITIONS
Brief Title
Improving Patient Reported Outcome Measures in Catheter Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Implanted with an Implantable Cardioverter Defibrillator (ICD) for more than 3 months before recruitment
- Previous episode of documented ventricular tachycardia requiring therapy from the ICD
- Impaired left or right ventricular heart function
- Willing and able to give written informed consent
You will not qualify if you...
- Planning to move away from the study site within 12 months if using postal completion of quality of life forms
- Unable to give informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo either catheter ablation of ventricular tachycardia (VT) or anti-arrhythmic drug (AAD) therapy as part of their treatment strategy.
Participants complete quality of life questionnaires at baseline, 1, 2, 3, 4, 6, 9, and 12 months
Duration - Up to 18 months
Participants' health-related quality of life is monitored over time to assess clinical effectiveness and cost-effectiveness of the treatments.
Quality of life assessments continue beyond treatment through scheduled questionnaire completions
Trial Site Locations
Total: 1 location
1
St Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
Research Team
Y
Yang Chen, BM BCh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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