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

NCT05203484 | Suspended DMC

• 1 other identifier: EMPIRE-VT
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia

Keywords

ischemic heart disease; implantable cardioverter-defibrillator; multielectrode mapping; Point-by-Point Mapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of intraprocedural data

  directly after procedure

• Rate of ICD shocks/therapies in the follow up period

  12 months

• VT Burden

  12 months

Study Arms (2)

Multielectrode mapping

EXPERIMENTAL

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

Point-by-Point Mapping

ACTIVE COMPARATOR

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

Interventions

Multielecotrde Mapping DEVICE

Multielectrode Mapping with Pentaray/Octaray

Multielectrode mapping

Point-by-point mapping DEVICE

Point-by-point mapping with QDot

Point-by-Point Mapping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helios Health Institute GmbH: lead

Study Sites (1)

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Aarsh Arya, PD

  leipzig heart centre

  STUDY CHAIR

• Gerhard Hindricks, Prof. Dr.

  leipzig heart centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 24, 2022
• Study Start: October 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)