Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

NCT05225935 | Completed

• 1 other identifier: CHUBX 2021/61
• Study Type: interventional
• Target: 119
• Locations: 4 countries
• Sites: 14

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.

Conditions

Ventricular Tachycardia

Keywords

Myocardial infarction; Ventricular Tachycardia; Catheter Ablation; Imaging; Cardiac computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Number of VT

  Baseline, Month 6, , Month 12

• Appropriate antitachycardia pacing from ICD >14 days after procedure

  Month 1, Month 6, Month 12

• Appropriate ICD shock >14 days after procedure

  Month 1, Month 6, Month 12

• Inappropriate ICD shock >14 days after procedure

  Month 1, Month 6, Month 12

• Electrical storm >14 days after procedure

  Month 1, Month 6, Month 12

Study Arms (2)

image-guided VT ablation strategy

EXPERIMENTAL

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

conventional VT ablation strategy

ACTIVE COMPARATOR

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

Interventions

image-guided VT ablation strategy 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

image-guided VT ablation strategy

conventional VT ablation strategy 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.

conventional VT ablation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• EIT Health: collaborator

Study Sites (14)

Medical University of Graz

Graz, Austria

Location

Public Hospital Elisabethinen Linz

Linz, Austria

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Limoges

Limoges, France

Location

APHP Salpétrière

Paris, France

Location

CHU de Bordeaux

Pessac, France

Location

CHU de Toulouse

Toulouse, France

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Rhön-Klinikum AG

Bad Neustadt an der Saale, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Asklepios Klinik St. Georg Hamburg

Hamburg, Germany

Location

Deutsches Herzzentrum München

München, Germany

Location

Inselspital, Universitätsspital Bern

Bern, Switzerland

Location

Vaudois University Hospital, Lausanne

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Frederic Sacher, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 7, 2022
• Study Start: June 29, 2022
• Primary Completion: December 22, 2023
• Study Completion: December 20, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

AU (2); DE (5); CH (2); FR (5)