image-guided VT ablation strategy
DeviceCatheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
NCT Number: NCT05225935
This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Medical University of Graz, Graz, Austria
Ventricular tachycardia ablation is a non-drug alternative for patients with recurrent VT and ischemic cardiomyopathy with a class 1 indication in the latest guidelines. However, it is poorly standardised and reserved to expert centres. Proof of concept studies have demonstrated that image-guided VT ablation is feasible, and that it may improve the efficiency of VT ablation.
Ablation strategy no longer relying on intracardiac 2-dimensional surface catheter measurements for target identification, but on 3- dimensional pre-operative images of the myocardium acquired by computed tomography (CT) would shorten the procedure, make it more reproducible and less dependent of the operator's experience without altering efficacy.
This randomized study will compare VT ablation based on substrate/VT isthmus identification via intracardiac catheter vs identification via pre-procedural CT-scan. Ablation will be performed with the same material.
Primary endpoint will be procedure duration. Secondary endpoints will compare efficacy and safety of both strategies as well as cost-effectiveness.
Expected results are a reduction procedure duration, without alteration of the efficacy for the CT-guided procedure with an improved medico-economic evaluation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
Catheter ablation will be performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits.
Time frame: Day 1
Procedure duration measured from the first introduction of a catheter in the cardiac chamber of interest (mainly left ventricle or epicardial space) to the end of the last radiofrequency application
Time frame: Baseline, Month 6, , Month 12
Number of VT
Time frame: Month 1, Month 6, Month 12
Number of appropriate antitachycardia pacing from ICD >14 days after procedure. for ventricular arrhythmia
Time frame: Month 1, Month 6, Month 12
Number of any appropriate ICD shock >14 days after procedure. The ICD shocks will be automatically recorded through the device logs and transmitted via remote monitoring whenever possible. Appropriate ICD therapies are defined as antitachycardia pacing or shock delivered
Time frame: Month 1, Month 6, Month 12
Number of any inappropriate ICD shock >14 days after procedure. The ICD shocks will be automatically recorded through the device logs and transmitted via remote monitoring whenever possible. - Inappropriate ICD therapies are defined as antitachycardia pacing or shock delivered for anything but ventricular arrhythmia
Time frame: Month 1, Month 6, Month 12
Number of electrical storm >14 days after procedure. Electrical storm is defined as 3 episodes of sustained VT/VF within 24 hours
Time frame: Month 1, Month 6, Month 12
Number of sustained VT not treated by ICD >14 days after procedure
Time frame: Month 1, Month 6, Month 12
Use of anti-arrhythmic drugs >30 days after procedure
Time frame: Month 12
Death
Time frame: Baseline, Month 1, Month 6, Month 12
Quality of life using EQ-5D-5L questionnaire: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: Day 1
Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Total one-year healthcare costs from a societal perspective : Cumulative over 12 months with medical consumption, informal care, and absence from work, all measured according to the time frame indicated down below
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Total one-year healthcare costs from a payer's perspective: Cumulative over 12 months with medical consumption, measured according to the time frame indicated down below
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Number of (quality-adjusted life-QALY) years: Cumulative over 12 months with EQ-5D-5L measured according to the time frame indicated down below
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per VT episode avoided (ratio): 12-month cumulative costs divided by cumulative number of VT in 12-months
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Incremental cost per additional day without a VT episode (ratio): 12-month cumulative costs divided by cumulative number of days without VT in 12 months
University Hospital, Bordeaux
Other
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)
Acronym: InEurHeart
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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