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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05225935
Other study ID # CHUBX 2021/61
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 29, 2022
Est. completion date March 30, 2025

Study information

Verified date January 2024
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 119
Est. completion date March 30, 2025
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years, - Indication for catheter ablation intervention with planned preoperative cardiac CT scan - Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury), - Presence of an implantable cardioverter defibrillator, or planned ID implantation before discharge, and - One of the following monomorphic VT events within last 6 months: - A: =3 episodes of VT treated with antitachycardia pacing (ATP), - B: =1 appropriate ICD shocks, - C: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor - D: Sustained VT recorded on 12 leads ECG in the absence of ICD - Highly effective contraception for women of childbearing potential, maintained during research procedures - Signed informed consent , - Affiliated to or beneficiary of a health insurance Exclusion Criteria: - Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent, - Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia, - Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves, - Have had a prior catheter ablation procedure for VT, - Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF), - Renal failure (Creatinine clearance <30 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year, - Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period, - Patient under legal protection

Study Design


Intervention

Device:
image-guided VT ablation strategy
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
conventional VT ablation strategy
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.

Locations

Country Name City State
Austria Medical University of Graz Graz
Austria Public Hospital Elisabethinen Linz Linz
France CHU de Clermont-Ferrand Clermont-Ferrand
France CHU de Limoges Limoges
France APHP Salpétrière Paris
France CHU de Bordeaux Pessac
France CHU de Toulouse Toulouse
Germany Rhön-Klinikum AG Bad Neustadt An Der Saale
Germany Evangelisches Krankenhaus Düsseldorf Düsseldorf
Germany Asklepios Klinik St. Georg Hamburg Hamburg
Germany Inuversitäres Herzzentrum Leipzig Leipzig
Germany Deutsches Herzzentrum München München
Switzerland Inselspital, Universitätsspital Bern Bern
Switzerland Vaudois University Hospital, Lausanne Lausanne
Switzerland Luzerner Kantonsspital Luzern

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux EIT Health

Countries where clinical trial is conducted

Austria,  France,  Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure duration 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 Day 1
Secondary Number of VT Number of VT Baseline, Month 6, , Month 12
Secondary Appropriate antitachycardia pacing from ICD >14 days after procedure Number of appropriate antitachycardia pacing from ICD >14 days after procedure. for ventricular arrhythmia Month 1, Month 6, Month 12
Secondary Appropriate ICD shock >14 days after procedure 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 Month 1, Month 6, Month 12
Secondary Inappropriate ICD shock >14 days after procedure 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 Month 1, Month 6, Month 12
Secondary Electrical storm >14 days after procedure Number of electrical storm >14 days after procedure. Electrical storm is defined as 3 episodes of sustained VT/VF within 24 hours Month 1, Month 6, Month 12
Secondary Sustained VT not treated by ICD >14 days after procedure Number of sustained VT not treated by ICD >14 days after procedure Month 1, Month 6, Month 12
Secondary anti-arrhythmic drugs Use of anti-arrhythmic drugs >30 days after procedure Month 1, Month 6, Month 12
Secondary Death Death Month 12
Secondary General health-related quality of life 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'. Baseline, Month 1, Month 6, Month 12
Secondary Radiofrequency (RF) applications Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii Day 1
Secondary Societal healthcare costs 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 Month 1, Month 3, Month 6, Month 9, Month 12
Secondary Payer healthcare costs 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 Month 1, Month 3, Month 6, Month 9, Month 12
Secondary Quality-adjusted life Number of (quality-adjusted life-QALY) years: Cumulative over 12 months with EQ-5D-5L measured according to the time frame indicated down below Month 1, Month 3, Month 6, Month 9, Month 12
Secondary Incremental cost per QALY gained Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs Month 1, Month 3, Month 6, Month 9, Month 12
Secondary Incremental cost per VT episode avoided Incremental cost per VT episode avoided (ratio): 12-month cumulative costs divided by cumulative number of VT in 12-months Month 1, Month 3, Month 6, Month 9, Month 12
Secondary Incremental cost per additional day without a VT episode 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 Month 1, Month 3, Month 6, Month 9, Month 12
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