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

Primary Purpose

Ventricular Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
image-guided VT ablation strategy
conventional VT ablation strategy
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Myocardial infarction, Ventricular Tachycardia, Catheter Ablation, Imaging, Cardiac computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz
  • Public Hospital Elisabethinen Linz
  • CHU de Clermont-Ferrand
  • CHU de Limoges
  • APHP Salpétrière
  • CHU de Bordeaux
  • CHU de Toulouse
  • Rhön-Klinikum AG
  • Evangelisches Krankenhaus Düsseldorf
  • Asklepios Klinik St. Georg Hamburg
  • Inuversitäres Herzzentrum Leipzig
  • Deutsches Herzzentrum München
  • Inselspital, Universitätsspital Bern
  • Vaudois University Hospital, Lausanne
  • Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

image-guided VT ablation strategy

conventional VT ablation strategy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of VT
Number of VT
Appropriate antitachycardia pacing from ICD >14 days after procedure
Number of appropriate antitachycardia pacing from ICD >14 days after procedure. for ventricular arrhythmia
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
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
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
Sustained VT not treated by ICD >14 days after procedure
Number of sustained VT not treated by ICD >14 days after procedure
anti-arrhythmic drugs
Use of anti-arrhythmic drugs >30 days after procedure
Death
Death
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'.
Radiofrequency (RF) applications
Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii
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
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
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
Incremental cost per QALY gained
Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs
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
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

Full Information

First Posted
January 25, 2022
Last Updated
March 3, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
EIT Health
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1. Study Identification

Unique Protocol Identification Number
NCT05225935
Brief Title
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia
Acronym
InEurHeart
Official Title
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
EIT Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Myocardial infarction, Ventricular Tachycardia, Catheter Ablation, Imaging, Cardiac computed tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
image-guided VT ablation strategy
Arm Type
Experimental
Arm Description
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
Arm Title
conventional VT ablation strategy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
image-guided VT ablation strategy
Intervention Description
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
Intervention Name(s)
conventional VT ablation strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedure duration
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of VT
Description
Number of VT
Time Frame
Baseline, Month 6, , Month 12
Title
Appropriate antitachycardia pacing from ICD >14 days after procedure
Description
Number of appropriate antitachycardia pacing from ICD >14 days after procedure. for ventricular arrhythmia
Time Frame
Month 1, Month 6, Month 12
Title
Appropriate ICD shock >14 days after procedure
Description
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
Time Frame
Month 1, Month 6, Month 12
Title
Inappropriate ICD shock >14 days after procedure
Description
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
Time Frame
Month 1, Month 6, Month 12
Title
Electrical storm >14 days after procedure
Description
Number of electrical storm >14 days after procedure. Electrical storm is defined as 3 episodes of sustained VT/VF within 24 hours
Time Frame
Month 1, Month 6, Month 12
Title
Sustained VT not treated by ICD >14 days after procedure
Description
Number of sustained VT not treated by ICD >14 days after procedure
Time Frame
Month 1, Month 6, Month 12
Title
anti-arrhythmic drugs
Description
Use of anti-arrhythmic drugs >30 days after procedure
Time Frame
Month 1, Month 6, Month 12
Title
Death
Description
Death
Time Frame
Month 12
Title
General health-related quality of life
Description
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'.
Time Frame
Baseline, Month 1, Month 6, Month 12
Title
Radiofrequency (RF) applications
Description
Proportion of Radiofrequency (RF) applications within isthmii identified by CT-Scan vs outside isthmii
Time Frame
Day 1
Title
Societal healthcare costs
Description
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
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12
Title
Payer healthcare costs
Description
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
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12
Title
Quality-adjusted life
Description
Number of (quality-adjusted life-QALY) years: Cumulative over 12 months with EQ-5D-5L measured according to the time frame indicated down below
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12
Title
Incremental cost per QALY gained
Description
Incremental cost per QALY gained (ratio): 12-month cumulative costs divided by 12-month cumulative QALYs
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12
Title
Incremental cost per VT episode avoided
Description
Incremental cost per VT episode avoided (ratio): 12-month cumulative costs divided by cumulative number of VT in 12-months
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12
Title
Incremental cost per additional day without a VT episode
Description
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
Time Frame
Month 1, Month 3, Month 6, Month 9, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic Sacher, MD, PhD
Phone
+33 557 65 64 71
Email
frederic.sacher@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert Cochet, MD, PhD
Phone
+33 557 65 65 42
Email
hubert.cochet@chu-bordeaux.fr
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD, PhD
Email
daniel.scherr@medunigraz.at
Facility Name
Public Hospital Elisabethinen Linz
City
Linz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Pürerfellner, MD, PhD
Email
helmut.puererfellner@ordensklinikum.at
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Massoullié, MD
Email
gmassoullie@chu-clermontferrand.fr
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Guy-Moyat, MD
Email
benoit.guy-moyat@chu-limoges.fr
Facility Name
APHP Salpétrière
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Gandjbakhch, MD, PhD
Email
estelle.gandjbakhch@aphp.fr
Facility Name
CHU de Bordeaux
City
Pessac
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Sacher, MD, PhD
Email
frederic.sacher@chu-bordeaux.fr
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Maury, MD, PhD
Email
maury.p@chu-toulouse.fr
Facility Name
Rhön-Klinikum AG
City
Bad Neustadt An Der Saale
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, MD, PhD
Email
thomas.deneke@campus-nes.de
Facility Name
Evangelisches Krankenhaus Düsseldorf
City
Düsseldorf
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD, PhD
Email
christian.meyer@evk-duesseldorf.de
Facility Name
Asklepios Klinik St. Georg Hamburg
City
Hamburg
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD, PhD
Email
s.willems@asklepios.com
Facility Name
Inuversitäres Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Arya, MD
Email
Arash.Arya@helios-gesundheit.de
Facility Name
Deutsches Herzzentrum München
City
München
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Bourier, MD
Email
bourier@dhm.mhn.de
Facility Name
Inselspital, Universitätsspital Bern
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Reichlin, MD
Email
tobias.reichlin@insel.ch
Facility Name
Vaudois University Hospital, Lausanne
City
Lausanne
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Pruvot, MD, PhD
Email
etienne.pruvot@chuv.ch
Facility Name
Luzerner Kantonsspital
City
Luzern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Berte, MD, PhD
Email
Benjamin.Berte@luks.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

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