Testing Objective Methods for Template Matching Ventricular Tachycardia and Pacemapping
NCT ID: NCT01170416
Last Updated: 2016-05-17
Study Results
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Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2010-07-31
2011-07-31
Brief Summary
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Detailed Description
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Objectives:
1. To quantify the similarity between BSPM waveforms during induced VT and during pacemapping or between two different pacing sites using two waveform comparison metrics, the correlation coefficient (CORR) and the root mean square error (RMSE) and to test the validity of these metrics as markers of proximity of the pacing site to the site of earliest ventricular activation.
2. To compare the accuracy with which the origin of ventricular tachycardia is localized via pacemapping by applying (BSPM), which uses data derived from 120 simultaneously acquired ECGs, to the accuracy of localization with different ECG subsets e.g. 12-lead ECG and X, Y and Z leads.
Patient and methods:
We anticipate that our patients will fall in one of the flowing 4 groups:
Group A:Patients with focal VT in structurally normal heart. Group B:Patients with scar related VT in which the exit site can be identified. Group C:Patients with scar related VT in which the exit site cannot be identified.Group D:Patients presenting with SVT.
For all groups, data for body-surface potential mapping (BSPM) will be recorded during induced VT (Group A\& B), pacing from virtual VT exit sites which are several points selected around the scar margin to represent the VT exit site (group C) or index pacing site which is a pacing site selected as a reference in the RV of patients presented with SVT (group D) and from different pacemapping sites including successful and unsuccessful ablation sites if applicable. All data will be imported into customized software.
The improvement in the arithmetic value of the two comparison metrics will be tested as the site of pacing approaches the site of earliest ventricular activation (Groups A\&B) or virtual VT exit sites in group C or the index pacing site (in group D). The best CORR and RMSE between the BSPM obtained during VT (in group A and B)/virtual VT exit sites (in group C) or index pacing site (group D) and different pacing sites (including successful and unsuccessful ablation sites) will be recorded. A simple linear regression will be used to compare the CORR and RMSE difference at each pacing site to distance between this pacing site and the successful ablation site as a surrogate of the best pace-match (in group A and B) or the corresponding virtual VT exit site (in group C) or index pacing site (group D). P value \<0.05 will be considered significant. The mean sensitivity, specificity, and positive- and negative-predictive accuracies of the arithmetic metrics in determining the VT origin/exit site will be determined. We will repeat the previous protocol using different ECG subsets including 12 lead ECGs and X, Y and Z leads. The predictive accuracies for different subsets of electrodes will be measured and compared to those derived from using the whole BSPM obtained from the 120 ECG leads.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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12-Lead Body Surface Mapping - Focal VT .
Body surface mapping (BSM) will be completed in patients with a defined focal VT site during the EP study.
12-lead body surface mapping
An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
12-Lead BSPM - Scar related VT, exit not identified
Body surface mapping will be competed on patients with scar related VT where the exit cannot be identified
12-lead body surface mapping
An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
12-Lead BSPM - Scar related VT exit identified
Body surface mapping will be competed on patients with scar related VT where the exit is identified
12-lead body surface mapping
An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
12-Lead BSPM - Supraventricular tachycardia
Body surface mapping will be completed on patients requiring an EP study for the treatment of symptoms related to supraventricular tachycardia
12-lead body surface mapping
An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
Interventions
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12-lead body surface mapping
An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
Eligibility Criteria
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Inclusion Criteria
* Patients referred for ablation of supraventricular tachycardia.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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John Sapp
OTHER
Responsible Party
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John Sapp
Electrophysiologist
Principal Investigators
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John A Sapp, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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Capital District Health Authority
Halifax, Nova Scotia, Canada
Countries
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References
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Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.
Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Della Bella P, Hindricks G, Jais P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association (EHRA); Registered Branch of the European Society of Cardiology (ESC); Heart Rhythm Society (HRS); American College of Cardiology (ACC); American Heart Association (AHA). EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm. 2009 Jun;6(6):886-933. doi: 10.1016/j.hrthm.2009.04.030. No abstract available.
Stevenson WG, Soejima K. Catheter ablation for ventricular tachycardia. Circulation. 2007 May 29;115(21):2750-60. doi: 10.1161/CIRCULATIONAHA.106.655720. No abstract available.
Stevenson WG. In: Wilber D, Packer DL, Stevenson WG, eds. Catheter Ablation of Cardiac Arrhythmias: Basic Concepts and clinical Application. 3rd Edition: Blackwell Publishing; 2008:315-324.
Gerstenfeld EP, Dixit S, Callans DJ, Rajawat Y, Rho R, Marchlinski FE. Quantitative comparison of spontaneous and paced 12-lead electrocardiogram during right ventricular outflow tract ventricular tachycardia. J Am Coll Cardiol. 2003 Jun 4;41(11):2046-53. doi: 10.1016/s0735-1097(03)00427-3.
American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (ACC/AHA/HRS Writing Committee to Develop Data Standards on Electrophysiology); Buxton AE, Calkins H, Callans DJ, DiMarco JP, Fisher JD, Greene HL, Haines DE, Hayes DL, Heidenreich PA, Miller JM, Poppas A, Prystowsky EN, Schoenfeld MH, Zimetbaum PJ, Goff DC, Grover FL, Malenka DJ, Peterson ED, Radford MJ, Redberg RF. ACC/AHA/HRS 2006 key data elements and definitions for electrophysiological studies and procedures: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (ACC/AHA/HRS Writing Committee to Develop Data Standards on Electrophysiology). Circulation. 2006 Dec 5;114(23):2534-70. doi: 10.1161/CIRCULATIONAHA.106.180199. Epub 2006 Nov 27. No abstract available.
Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC, Jr., Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006;114(10):e385-484.
de Bakker JM, van Capelle FJ, Janse MJ, Tasseron S, Vermeulen JT, de Jonge N, Lahpor JR. Slow conduction in the infarcted human heart. 'Zigzag' course of activation. Circulation. 1993 Sep;88(3):915-26. doi: 10.1161/01.cir.88.3.915.
Other Identifiers
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SP12
Identifier Type: -
Identifier Source: org_study_id
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