Catheter Ablation Clinical Trial
— MANIaC-PVCOfficial title:
MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures (MANIaC-PVC Study). A Randomized, Multicenter Study
Verified date | October 2020 |
Source | Centro Medico Teknon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years. - Indication for PVC ablation. - Signed informed consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Antonio Berruezo, MD, PhD | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Centro Medico Teknon |
Spain,
Andreu D, Berruezo A, Fernández-Armenta J, Herczku C, Borràs R, Ortiz-Pérez 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Penela D, De Riva M, Herczku C, Catto V, Pala S, Fernández-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. — View Citation
Penela D, Van Huls Van Taxis C, Van Huls Vans Taxis C, Aguinaga L, Fernández-Armenta J, Mont L, Castel MA, Heras M, Tolosana JM, Sitges M, Ordóñez 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. Erratum in: J Am Coll Cardiol. 2014 Feb 25;63(7):746. Van Huls Vans Taxis, Carine [corrected to Van Huls Van Taxis, Carine]. — View Citation
Stevenson WG, Soejima K. Recording techniques for clinical electrophysiology. J Cardiovasc Electrophysiol. 2005 Sep;16(9):1017-22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Secondary | Mapping time | 12 months | ||
Secondary | Number of mapped chambers | 12 months | ||
Secondary | 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. | 12 months | |
Secondary | 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). | 12 months | |
Secondary | Radiofrequency (RF) time | 12 months | ||
Secondary | Number of RF applications | 12 months | ||
Secondary | Acute procedure success | Complete elimination of the PVC at the end of the procedure. | 12 months | |
Secondary | Clinical success | Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure. | 1 month |
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