Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart)

Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: image-guided VT ablation strategy; Device: conventional VT ablation strategy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz
  • Linz, Austria
    • Public Hospital Elisabethinen Linz
• France
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrand
  • Limoges, France
    • CHU de LImoges
  • Paris, France
    • APHP Salpétrière
  • Pessac, France
    • CHU de Bordeaux
  • Toulouse, France
    • CHU de Toulouse
• Germany
  • Bad Neustadt an der Saale, Germany
    • Rhön-Klinikum AG
  • Düsseldorf, Germany
    • Evangelisches Krankenhaus Düsseldorf
  • Hamburg, Germany
    • Asklepios Klinik St. Georg Hamburg
  • München, Germany
    • Deutsches Herzzentrum München
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein
• Switzerland
  • Bern, Switzerland
    • Inselspital, Universitätsspital Bern
  • Lausanne, Switzerland
    • Vaudois University Hospital, Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: conventional VT ablation strategy; Catheter ablation 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of VT	Number of VT	Baseline, Month 6, , Month 12
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
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
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
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
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
anti-arrhythmic drugs	Use of anti-arrhythmic drugs >30 days after procedure	Month 1, Month 6, Month 12
Death	Death	Month 12
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
Radiofrequency (RF) applications	Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii	Day 1
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: EIT Health
• Investigators: Principal Investigator: Frederic Sacher, MD, PhD, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Sacher F, Reichlin T, Le Bloa M, Massoulie G, Waintraub X, Maury P, Scherr D, Tixier R, Guy-Moyat B, Duchateau J, Meyer C, Sermesant M, Plant A, Rousset M, Gunawardene MA, Bronnec N, Gandjbakhch E, Sacristan B, Georget A, Ditac G, Azzouz S, Haissaguerre M, Willems S, Derval N, Tilz RR, Hocini M, Deneke T, Pambrun T, Rutten-van Molken M, Purerfellner H, Englert F, Sauer E, Jais P, Benard A, Cochet H. Computed tomography-guided vs conventional catheter ablation for ventricular tachycardia: the InEurHeart trial. Eur Heart J. 2026 Feb 11:ehag052. doi: 10.1093/eurheartj/ehag052. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; Catheter Ablation; Myocardial infarction; Ventricular Tachycardia; Cardiac computed tomography
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Tachycardia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Tachycardia, Ventricular
• Other Study ID Numbers: CHUBX 2021/61; 2022-A00075-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No