Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— InEurHeart  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05225935
• Other study ID #: CHUBX 2021/61
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

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