Improving quality of life measures for patients with ventricular tachycardia
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 is trying to see if checking in more often on how patients with ventricular tachycardia feel about their quality of life can help doctors understand the benefits of a heart procedure better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04499326 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether more frequent measurement of patient-reported outcome measures (PROMs), specifically health-related quality of life (HRQL), can enhance the assessment of clinical effectiveness and cost-effectiveness of catheter ablation for ventricular tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD). It aims to determine the feasibility of regular HRQL monitoring to better capture the clinical narrative and quality of life changes in patients suffering from severe heart failure. The study will utilize validated quality of life questionnaires, such as EQ-5D and C-CAP, to gather data on patient experiences. Conducted at St Bartholomew's Hospital in London, it will involve patients identified through established referral pathways.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with an ICD implanted for more than three months and a history of documented VT requiring therapy.
Not a fit: Patients who are planning to relocate away from the study site within 12 months or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment of treatment effectiveness and better quality of life for patients undergoing catheter ablation for ventricular tachycardia.
How similar studies have performed: Other studies have shown success in using frequent PROMs to evaluate treatment effectiveness, but this specific approach in the context of VT ablation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Yang Chen, BM BCh
- Email: yang.chen@nhs.net
- Phone: 02034165000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.