Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease (EMPIRE-VT)

Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease - A Prospective, Randomised Single Centre Trial

VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.

Study Overview

• Status: Suspended
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Multielecotrde Mapping; Device: Point-by-point mapping

Detailed Description

Catheter Ablation in Patient with VT and ischemic heart disease has shown a beneficial effect in terms of VT Recurrence and Quality of life. The short-term outcome of catheter Ablation in Patients with this particular disease is good, but VT recurrence during long-term follow up is as high as 50-70%.

An integral Part of the Ablation procedure is the substance guided Mapping for localisation of low Voltage areas, late diastolic or fractioned potentials, as possible substrate for VT maintenance. These diastolic pathways, which represent slow conducting myocardium, are the major prerequisites for Reentry and thus for ventricular tachycardia.

Commonly these diastolic pathways are found in myocardial scar after infarction. Cardiac MRI can help to visualize these scars. In Patients with non-ischemic cardiomyopathy, the physician has to rely on intraprocedural Mapping and localisation of pathologic signals mentioned above.

In the last few years, the use of Multielectrode Mapping catheters becomes more and more part of complex EP procedures, mainly due to a high spatio temporal resolution, thereby reducing the overall Mapping time while maintaining the same primary endpoint of VT-non-inducibility compared to Point-by-Point Mapping.

There is growing evidence, that Multielectrode Mapping is associated with lesser mapping and procedure time, while generating more elecatroanatomical points (and thus more information regarding the arrhythmogenic substrate, responsible for VT maintenance).

Currently there is considerable uncertainty as to whether the reduced mapping and procedure time of Multielectrode Mapping will have an effect on the recurrence of ventricular tachycardia.

Procedure time of catheter ablation in patients with scar mediated ventricular tachycardia is directly correlated to hospital mortality.

Yet there are no prospective studies, which evaluate the effect of the aforementioned Mapping systems in the recurrence of ventricular tachycardia in comparison to conventional mapping techniques.

The objective of the trial is to demonstrate that Multielectrode Mapping in patients with ventricular tachycardia with structural (on inflammatory) is not inferior to conventional Mapping techniques with respect to VT Recurrence.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Symptomatic ventricular tachycardia with/without ICD and underlying ischemic
3. No need for coronary revascularisation therapy based on coronary angiography or Cardiac MRI
4. Class I or IIa indication for catheter ablation (according to 2015 Guidelines of the European Society of Cardiology for the management of ventricular tachycardias).
5. Signed informed consent.

Exclusion Criteria:

1. Patients with ventricular assist device
2. Reversible causes of ventricular tachycardia (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection/acute myocarditis)
3. Recent cardiovascular event including myocardial infarction, percutaneous intervention, valve or cardiac bypass surgery
4. Previous VT ablation within the last 3 months
5. Patients with ventricular tachycardia and known atrial fibrillation with sufficient antiarrhythmic drug therapy regarding rhythm control of atrial fibrillation
6. Medical conditions limiting the expected survival to < 1 year
7. On the waiting list for heart transplant.
8. Participation in any other randomized controlled trial
9. Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy)
10. Subjects under legal supervision or guardianship
11. Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multielectrode mapping; Participants assigned to the Multielectrode Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with either a Pentaray or Octaray catheter (Biosense Webster; each 45 catheters, randomly allocated). Catheter ablation of potential diastolic pathways and Scar homogenisation will be performed with a irrigated 3.5mm tip catheter (QDot; Biosense Webster).	Device: Multielecotrde Mapping; Multielectrode Mapping with Pentaray/Octaray
Active Comparator: Point-by-Point Mapping; Participants assigned to the Point-by-Point Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with a QDot catheter (Biosense Webster). Catheter ablation of potential diastolic pathways and scar homogenisation will also be performed with the QDot catheter.	Device: Point-by-point mapping; Point-by-point mapping with QDot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VT recurrence	Time to VT-recurrence based ICD Recordings in dependence of the Mapping modality: Multielectrodemapping with Pentaray/Octaray (Biosense webster) or conventional Point-by-Point mapping with QDOT (Biosense webster)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of intraprocedural data	EAM Points, total mapping and overall procedure time, Mapping quality/accuracy (mapping points used/points acquired), Scar Area, number of RF ablations, RF Ablation time, total fluoroscopy time) in both arms	directly after procedure
Rate of ICD shocks/therapies in the follow up period	Total number and date of ATPs/ ICD Shocks, measured by the ICD recordings during the follow up visits	12 months
VT Burden	Total number of VT episodes recorded by the ICD in the follow up period	12 months

Collaborators and Investigators

• Sponsor: Leipzig Heart Institute GmbH
• Investigators: Study Chair: Aarsh Arya, PD, leipzig heart centre; Study Chair: Gerhard Hindricks, Prof. Dr., leipzig heart centre

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: ischemic heart disease; implantable cardioverter-defibrillator; multielectrode mapping; Point-by-Point Mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Arrhythmias, Cardiac; Coronary Disease; Cardiac Conduction System Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Recurrence; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: EMPIRE-VT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No