Proposed Outcome Set for Interventional Trials In Ventricular Tachycardia - POSITI-VT

Ventricular tachycardia (VT) is a potentially fatal cardiac arrhythmia, resulting from electrical disturbance originating from an abnormal focus within the ventricular myocardium. Catheter ablation for VT, is a minimally invasive treatment performed in the cardiac catheter laboratory to identify potential arrhythmogenic substrate in areas of scar, targetting critical components for the development of VT. It has been shown to reduce recurrence as well as be life-saving in cases of incessant VT, with the current guidelines recommending CA as a class 1 indication when AADs have failed or if the patient becomes intolerant to them.

Recently, the role of catheter ablation has grown, mainly due to an enhanced understanding of the pathological basis of arrhythmia along with continued technological improvements, with some studies suggesting prophylactic catheter for VT as the first therapy. As the field continues to evolve, clinical benefits derived from VT ablation will increase further, and its use might increasingly be seen as a first-line therapy. However, the heterogeneity of the patients with VT enrolled in clinical studies and the lack of common reporting standards make meaningful comparisons of studies difficult. Pragmatic trials, aimed at evaluating the effectiveness of interventions in routine clinical practice, require careful selection of outcomes that are relevant to both patients and clinicians. It is therefore important to define the relevant outcomes in this cohort of patients before establishing the tools to measure these outcomes.


Contributors

Deepti Ranganathan

Supervisor- Atul Verma, McGill University and president of the Canadian Heart Rhythm Society

Further Study Information

Current Stage: Ongoing
Date: January 2025 - January 2026
Funding source(s): None


Health Area

Disease Category: Heart & circulation

Disease Name: Ventricular tachycardia

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Procedure

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Survey
- Systematic review

Initially a systematic literature review will be performed to identify a comprehensive list of candidate outcomes that have been measured in trials of interventions for patients undergoing CA for VT. These candidate outcomes will then be categorised into distinct groups of patient-reported and clinician-reported outcomes. Support for the literature review will be provided by McGill University with access to dedicated research librarians.

Following this a 'long list' of outcomes will be finalised and an online Delphi process will then be conducted with the relevant stakeholders to develop a core outcome set. The results of this COS is aimed to be submitted for presentsation at international cardiac electrophysiology conferences and for publication in a peer-reviewed journal. Furthermore, we plan to publicise the results of our study on social media and reach out to regulatory bodies, clinical trial registries as well as pharmaceutical companies involved in clinical research to encourage the adoption of the COS in future studies.

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