Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

NCT ID: NCT05225935

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2024-12-20

Brief 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.

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

image-guided VT ablation strategy

Intervention Type: DEVICE

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 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.

Group Type: ACTIVE_COMPARATOR

conventional VT ablation strategy

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EIT Health

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Sacher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Medical University of Graz

Graz, , Austria

Public Hospital Elisabethinen Linz

Linz, , Austria

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, , France

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Rhön-Klinikum AG

Bad Neustadt an der Saale, , Germany

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, , Germany

Asklepios Klinik St. Georg Hamburg

Hamburg, , Germany

Deutsches Herzzentrum München

München, , Germany

Inselspital, Universitätsspital Bern

Bern, , Switzerland

Vaudois University Hospital, Lausanne

Lausanne, , Switzerland

Countries

Austria; France; Germany; Switzerland

Other Identifiers

CHUBX 2021/61

Identifier Type: -

Identifier Source: org_study_id