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Ventricular Premature ComplexesPhase 4MANIaC-PVCNCT03340922

MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

A Phase 4 study testing Automatic annotation of LAT (WF-method) and Manual annotation of LAT (M-method) in people with Ventricular Premature Complexes and Catheter Ablation, run by Centro Medico Teknon at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Automatic annotation of LAT (WF-method) and Manual annotation of LAT (M-method)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
26 Jun 2018to 31 Aug 2020
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years.
  • Indication for PVC ablation.
  • Signed informed consent.

Who cannot join

  • Age < 18 years.
  • Pregnancy.
  • PVC ablation procedures guided by pace-mapping (PASO® module); eg. low burden of PVCs during the study, mechanical impact during activation mapping.
  • Impossibility to perform activation mapping with the required density of points in the region of interest (see section 4.5.3).
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Antonio Berruezo, MD, PhD

    Barcelona, 08022

Other trials in Spain

About this study

Official title: MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures (MANIaC-PVC Study). A Randomized, Multicenter Study

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

Read the detailed description

This is a prospective, randomized, controlled and international multicenter study. The investigators aim to analyze the accuracy of LAT annotation using a novel algorithmic method (Wavefront, CARTO, Biosense Webster, Diamond Bar, California, USA) (WF), based on automatic annotation of the maximal negative slope of the unipolar electrogram (U-EGM) within the window demarcated by the B-EGM, by comparison with conventional, manual annotation in a multicenter cohort of patients referred for PVC ablation. Further on, the automatic annotation of LAT will be aided by an ECG recognition pattern algorithm (included in the last version of CARTO), which is intended to avoid wrong annotation of ventricular complexes other than the clinical PVC. The investigators hypothesize that automatic LAT annotation (using WF and the ECG recognition algorithm) could be superior to conventional, manual annotation in terms of mapping success and could reduce both procedure time and radiofrequency time.

Being tested
Automatic annotation of LAT (WF-method), Manual annotation of LAT (M-method)
Keywords
premature ventricular complex, catheter ablation, activation mapping, wavefront
Medical subject headings
Ventricular Premature Complexes

What participants receive

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

  • Automatic annotation of LAT (WF-method)Device

    Also called Wavefront

    Automatic annotation of LAT during PVC activation mapping. Acquisition of points will be automatically performed using the Wavefront (WF) annotation tool integrated into CARTO navigation system.

  • Manual annotation of LAT (M-method)Device

    Also called Manual

    Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.

Study groups in NCT03340922
Study groupRoleWhat they receive
Automatic annotation of LAT (WF-method)ExperimentalThe annotation of LAT in each acquired point will be automatically performed using the LAT annotation tool integrated into CARTO navigation system, called Wavefront (WF). Automatic annotation of LAT performed by the CARTO system uses the maximum negative slope of the distal U-EGM to set the timing of the mapping annotation, displayed on the corresponding B-EGM. Additionally, the automatic annotation of LAT will be aided by an ECG recognition pattern algorithm (included in the last version of CARTO), which is intended to avoid wrong annotation of ventricular complexes other than the clinical PVC.
Receives: Device: Automatic annotation of LAT (WF-method)
Manual annotation of LAT (M-method)Active comparatorA detailed electrocardiogram (ECG)-gated activation map of the chamber of interest will be acquired using the CARTO navigation system. An experienced electrophysiologist will perform the annotation of LAT in each acquired point. The LAT will be measured from the onset of B-EGM (earliest positive or negative deflection) of the distal dipole of the mapping catheter to the defined reference. The use of the U-EGM as a guidance to identify the real onset of B-EGM will be decided under electrophysiologist criteria.
Receives: Device: Manual annotation of LAT (M-method)

What is being measured

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

  1. Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description

    Mapping success will be defined as complete PVC abolition after RF applications at the earliest activation site (EAS) identified using the assigned mapping approach. A maximum of 2 RF applications with appropriate parameters (contact force, impedance drop, catheter stability) during a maximum of 45 seconds will be allowed. If the PVC is not abolished after 2 RF applications with appropriate parameters, mapping will not be considered successful.

    Measured: 12 months

Secondary outcomes (8)

  1. Mapping time

    Measured: 12 months

  2. Number of mapped chambers

    Measured: 12 months

  3. Accuracy of a proposed algorithm for selection of first chamber to map

    In the case of PVCs arising from ventricular outflow tracts, we propose an algorithm to avoid subjective criteria, and to deal with eventual wrong selection of the first mapped chamber, leading to unnecessary RF applications. This algorithm involves a step-by-step analysis of the PVC-ECG morphology: precordial R/S transition and presence of one or more of the following clinical items, which have been previously related with a left origin: male gender, hypertension, or age > 50 years.

    Measured: 12 months

  4. Number of target points

    Target point is defined as any suspected PVC-site of origin where RF is delivered according to mapping data. Therefore, for one case there can be found a single target point with multiple RF applications, or multiple target points with one single RF application. The maximum distance between 2 RF applications to be considered at the same target point will be defined as 5 mm (equivalent to a 1-cm2 area).

    Measured: 12 months

  5. Radiofrequency (RF) time

    Measured: 12 months

  6. Number of RF applications

    Measured: 12 months

  7. Acute procedure success

    Complete elimination of the PVC at the end of the procedure.

    Measured: 12 months

  8. Clinical success

    Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure.

    Measured: 1 month

Timeline

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

  1. First posted14 Nov 2017
  2. Study start26 Jun 2018
  3. Primary completion31 May 2020
  4. Study completion31 Aug 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, controlled and international multicenter study. All patients who fulfill the inclusion criteria will be consecutively enrolled and randomized on a 1:1 basis to each of the LAT annotation systems (WF vs. M-method) before the ablation procedure. Ablation will be directed to the earliest activation site identified with the assigned annotation system. Any change of the assigned annotation system during the procedure won't be allowed, thus being a reason for justifying study exclusion.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03340922
Sponsor's protocol ID
Wavefront
Acronym
MANIaC-PVC
Status last verified
Oct 2020
First submitted
3 Nov 2017
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stevenson WG, Soejima K. Recording techniques for clinical electrophysiology. J Cardiovasc Electrophysiol. 2005 Sep;16(9):1017-22. doi: 10.1111/j.1540-8167.2005.50155.x.

    PubMed 16174026

  • Liuba I, Walfridsson H. Activation mapping of focal atrial tachycardia: the impact of the method for estimating activation time. J Interv Card Electrophysiol. 2009 Dec;26(3):169-80. doi: 10.1007/s10840-009-9437-0. Epub 2009 Oct 29.

    PubMed 19866350

  • Ndrepepa G, Caref EB, Yin H, el-Sherif N, Restivo M. Activation time determination by high-resolution unipolar and bipolar extracellular electrograms in the canine heart. J Cardiovasc Electrophysiol. 1995 Mar;6(3):174-88. doi: 10.1111/j.1540-8167.1995.tb00769.x.

    PubMed 7620643

  • El Haddad M, Houben R, Stroobandt R, Van Heuverswyn F, Tavernier R, Duytschaever M. Novel algorithmic methods in mapping of atrial and ventricular tachycardia. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):463-72. doi: 10.1161/CIRCEP.113.000833. Epub 2014 May 14.

    PubMed 24829224

  • Andreu D, Berruezo A, Fernandez-Armenta J, Herczku C, Borras R, Ortiz-Perez JT, Mont L, Brugada J. Displacement of the target ablation site and ventricles during premature ventricular contractions: relevance for radiofrequency catheter ablation. Heart Rhythm. 2012 Jul;9(7):1050-7. doi: 10.1016/j.hrthm.2012.02.018. Epub 2012 Feb 15.

    PubMed 22342861

  • Penela D, De Riva M, Herczku C, Catto V, Pala S, Fernandez-Armenta J, Acosta J, Cipolletta L, Andreu D, Borras R, Rios J, Mont L, Brugada J, Carbucicchio C, Zeppenfeld K, Berruezo A. An easy-to-use, operator-independent, clinical model to predict the left vs. right ventricular outflow tract origin of ventricular arrhythmias. Europace. 2015 Jul;17(7):1122-8. doi: 10.1093/europace/euu373. Epub 2015 Feb 10.

    PubMed 25672982

  • Penela D, Van Huls Van Taxis C, Van Huls Vans Taxis C, Aguinaga L, Fernandez-Armenta J, Mont L, Castel MA, Heras M, Tolosana JM, Sitges M, Ordonez A, Brugada J, Zeppenfeld K, Berruezo A. Neurohormonal, structural, and functional recovery pattern after premature ventricular complex ablation is independent of structural heart disease status in patients with depressed left ventricular ejection fraction: a prospective multicenter study. J Am Coll Cardiol. 2013 Sep 24;62(13):1195-202. doi: 10.1016/j.jacc.2013.06.012. Epub 2013 Jul 10.

    PubMed 23850913

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Automatic annotation of LAT (WF-method) and Manual annotation of LAT (M-method) in people with Ventricular Premature Complexes and Catheter Ablation, run by Centro Medico Teknon at 1 site in Spain.

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 6 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: finished, as of the sponsor's last update on 20 Oct 2020. 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description (time frame: 12 months). 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 NCT03340922, which also lists 7 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 20 Oct 2020.

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