NCT05713357

Brief Summary

Patients with ischemic ventricular tachycardia (VT) are frequently treated with radiofrequency catheter ablation. The efficacy of catheter ablation is limited for various reasons; one of those being incomplete myocardial and inhomogenous scar tissue damage due to suboptimal ablation lesions. The aim of our study is to reassess initially ablated endocardial areas in a repeated mapping procedure. Initial lesion parameters will be studied in areas with conduction recovery at repeated mapping procedure. Also, VT inducibility will be correlated to the extent and characteristics of areas with recovered conduction.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
0mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2023Jul 2026

First Submitted

Initial submission to the registry

January 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

January 15, 2023

Last Update Submit

March 16, 2023

Conditions

Ischemic CardiomyopathyVentricular Tachycardia

Keywords

Catheter AblationRepeated Mapping

Outcome Measures

Primary Outcomes (2)

  • Absence of electrical activity in previously ablated areas

    Absent electrical activity in segments of the left ventricle ablated at initial procedure - assessed according to 17 segment model of the left ventricle, using three-dimensional electro-anatomic mapping system and high-density mapping tools. Absence of electrical activity in previously ablated segments will be regarded as a positive outcome. Presence of electrical activity will be regarded as recurrence of conduction and considered a negative outcome and a measure of procedural failure.

    3 months

  • Inducibility of ventricular tachycardia at repeat procedure

    Inability to induce ventricular tachycardia with programed stimulation at repeat procedure will be considered a positive outcome. Inducibility of ventricular tachycardia will be considered a negative outcome and a measure of procedural failure.

    3 months

Secondary Outcomes (1)

  • Recurrence of ventricular tachycardia

    1 year

Interventions

Catheter ablationPROCEDURE

Endocardial catheter ablation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic cardiomyopathy with a clear indication to undergo catheter ablation for treatment of sustained ventricular tachycardia according to recognized and current guidelines (ESC and/or HRS).

You may qualify if:

  • ischemic heart disease,
  • sustained ventricular tachycardia,
  • implanted (or scheduled for implantation) cardiac electrical device with ability to record and store intracardiac electrograms

You may not qualify if:

  • nonischemic cardiomyopathy,
  • need for epicardial access to the substrate for treatment of ventricular tachycardia,
  • any severe acute organ damage beyond cardiomyopathy that could potentialy omit remapping procedure after 3 months,
  • any terminal disease with expected survival of less than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (6)

  • Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.

    PMID: 26320108BACKGROUND

  • Aktas MK, Younis A, Zareba W, Kutyifa V, Klein H, Daubert JP, Estes M, McNitt S, Polonsky B, Goldenberg I. Survival After Implantable Cardioverter-Defibrillator Shocks. J Am Coll Cardiol. 2021 May 25;77(20):2453-2462. doi: 10.1016/j.jacc.2021.03.329.

    PMID: 34016257BACKGROUND

  • Pedersen CT, Kay GN, Kalman J, Borggrefe M, Della-Bella P, Dickfeld T, Dorian P, Huikuri H, Kim YH, Knight B, Marchlinski F, Ross D, Sacher F, Sapp J, Shivkumar K, Soejima K, Tada H, Alexander ME, Triedman JK, Yamada T, Kirchhof P, Lip GY, Kuck KH, Mont L, Haines D, Indik J, Dimarco J, Exner D, Iesaka Y, Savelieva I; EP-Europace,UK. EHRA/HRS/APHRS expert consensus on ventricular arrhythmias. Heart Rhythm. 2014 Oct;11(10):e166-96. doi: 10.1016/j.hrthm.2014.07.024. Epub 2014 Aug 30. No abstract available.

    PMID: 25179489BACKGROUND

  • Fernandez-Armenta J, Soto-Iglesias D, Silva E, Penela D, Jauregui B, Linhart M, Bisbal F, Acosta J, Fernandez M, Borras R, Villuendas R, Cano L, Guasch E, Mont L, Berruezo A. Safety and Outcomes of Ventricular Tachycardia Substrate Ablation During Sinus Rhythm: A Prospective Multicenter Registry. JACC Clin Electrophysiol. 2020 Oct 26;6(11):1435-1448. doi: 10.1016/j.jacep.2020.07.028.

    PMID: 33121673BACKGROUND

  • Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

    PMID: 27149033BACKGROUND

  • Oloriz T, Baratto F, Trevisi N, Barbaro M, Bisceglia C, D'Angelo G, Yamase M, Paglino G, Radinovic A, Della Bella P. Defining the Outcome of Ventricular Tachycardia Ablation: Timing and Value of Programmed Ventricular Stimulation. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005602. doi: 10.1161/CIRCEP.117.005602.

    PMID: 29545359RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Matevž Jan, MD

    University Medical Centre Ljubljana

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Electrophysiology Specialist, Principal Investigator

Study Record Dates

First Submitted

January 15, 2023

First Posted

February 6, 2023

Study Start

March 15, 2023

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)