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Ischemic CardiomyopathyREMAP-VTNCT05713357

Repeated Endocardial Mapping for Efficacy Assessment After Catheter Ablation for Ischemic Ventricular Tachycardia

An observational study of Ischemic Cardiomyopathy and Ventricular Tachycardia, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Catheter ablation
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteSlovenia
Study dates
15 Mar 2023to 1 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • University Medical Centre Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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.

Read the detailed description

Patients with ischemic ventricular tachycardia and implanted defibrillatior (ICD) will be sent to catheter ablation according to current guidelines (ESC and/or HRS). At the initial procedure the scar will be mapped with an ablation catheter and a high density catheter and all abnormal endocardial electrical potentials will be marked on a three-dimensional electro-anatomical (3DEAM) map; late potentials, local abnormal ventricular activity and decrement evoked electrical potentials. Afterwards, programed ventricular stimulation will be performed with an intent to induce sustained ventricular tachycardia. Imaging derived three-dimensional reconstructions of the ischemic scar will be used according to the operator's discretion.

All regions with abnormal endocardial electrical potentials will be ablated with an irrigated, contact force enabled catheter with a power setting of 30-50W. The aim during each energy delivery will be near-field electrical signal dissapearance or absence of myocardial capture at high energy local electrical stimulation. All ablated regions will be re-mapped during the same procedure with a high density mapping catheter. Additional ablation will be performed until all near-field electrical signals are be abolished.

The endpoint of each procedure will be absence of near-field electrical signals in the ablated areas and noninducibility of sustained ventricular tachycardia at the repeated programed ventricular stimulation.

After 1-3 months all patients will have a re-mapping procedure with a high density catheter. Programmed ventricular stimulation will be performed. If any sustained ventricular tachycardia will be induced or if any residual abnormal endocardial electrical potentials will be found in previously ablated regions, additional ablations will be performed with identical ablation settings and endpoints as in the initial procedure.

All areas previously ablated and with recovered electrical conduction will be identified, marked on the 3DEAM map and used for analysis with inclusion of ablation parameters and findings at the initial procedure and (non)inducibility of the sustained ventricular tachycardia at the repeat procedure.

Patients will be followed-up ICD interrogation at scheduled ambulatory visits or reports from emergency or other department using recorded electrocardiograms (ECG).

Being tested
Catheter ablation
Keywords
Catheter Ablation, Repeated Mapping
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablationProcedure or surgery

    Endocardial catheter ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (1)

  1. Recurrence of ventricular tachycardia

    Recurrence of ventricular tachycardia detected with an implanted electrical device (ICD, CRT-D of ILR) during the follow up period

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start15 Mar 2023
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713357
Sponsor's protocol ID
VT remap
Acronym
REMAP-VT
Status last verified
Mar 2023
First submitted
15 Jan 2023
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26320108

  • 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.

    PubMed 34016257

  • 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.

    PubMed 25179489

  • 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.

    PubMed 33121673

  • 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.

    PubMed 27149033

  • 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.

    PubMed 29545359

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Cardiomyopathy and Ventricular Tachycardia, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of electrical activity in previously ablated areas (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05713357, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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