Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

Not Applicable

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: conventional VT ablation strategy; Device: image-guided VT ablation strategy

• Registration Number: NCT05225935
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-07
• Study Start: 2022-06-29
• Primary Completion: 2023-12-22
• Study Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional VT ablation strategy	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.
image-guided VT ablation strategy	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

Primary Outcome Measures

Name	Time	Method
Procedure duration	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

Secondary Outcome Measures

Name	Time	Method
Number of VT	Baseline, Month 6, , Month 12	Number of VT
Appropriate ICD shock >14 days after procedure	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
Sustained VT not treated by ICD >14 days after procedure	Month 1, Month 6, Month 12	Number of sustained VT not treated by ICD \>14 days after procedure
anti-arrhythmic drugs	Month 1, Month 6, Month 12	Use of anti-arrhythmic drugs \>30 days after procedure
Inappropriate ICD shock >14 days after procedure	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
Electrical storm >14 days after procedure	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
Appropriate antitachycardia pacing from ICD >14 days after procedure	Month 1, Month 6, Month 12	Number of appropriate antitachycardia pacing from ICD \>14 days after procedure. for ventricular arrhythmia
Death	Month 12	Death
Payer healthcare costs	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
Incremental cost per QALY gained	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
General health-related quality of life	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'.
Quality-adjusted life	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
Incremental cost per VT episode avoided	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
Radiofrequency (RF) applications	Day 1	Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii
Societal healthcare costs	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
Incremental cost per additional day without a VT episode	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

Trial Locations

Locations (14)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

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

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