Testing Objective Methods for Template Matching Ventricular Tachycardia and Pacemapping

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ClinicalTrials.gov Identifier: NCT01170416

Recruitment Status : Completed

First Posted : July 27, 2010

Last Update Posted : May 17, 2016

Sponsor:

Information provided by (Responsible Party):

John Sapp, Nova Scotia Health Authority

Study Description

Brief Summary:

Patients sometimes suffer from life-threatening abnormal heart racing that originates from the lower chamber of the heart. These patients will often need an implantable defibrillator which has the ability to shock the heart back to a normal heart rhythm, but this does not prevent them from getting frequent recurrences of the bad heart rhythm needing shocks from the device. This can be painful and potentially harmful. Medicines to prevent recurrences of shocks are not very effective and have many side effects. An alternative to medicines for this is a procedure called a catheter ablation in which a wire is passed up through the blood vessels of the leg into the heart and used to find the short circuits which cause the dangerous heart rhythm. When the spot causing the trouble is found, the investigators can burn it ("ablate" it). This procedure is challenging and methods are needed to make it more effective and easier to do. One of the main ways for finding the short circuits involves using the electrocardiogram (the "ECG"). The regular ECG is simplistic and only makes use of recordings from 10 sites (6 precordial sites and 4 sites on both upper and lower limbs) on the body surface. The investigators are testing whether making recordings from 120 sites on the chest and back and using special computerized analysis of the recordings can help make catheter ablation for dangerous heart rhythms more effective.

Condition or disease	Intervention/treatment
Ventricular Tachycardia	Other: 12-lead body surface mapping

Show Detailed Description

Study Design


Study Type :	Observational
Actual Enrollment :	20 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Quantitative Measurements Comparing Body Surface Potentials During Pacemapping and Spontaneous Ventricular Tachycardia
Study Start Date :	July 2010
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Catecholaminergic polymorphic ventricular tachycardia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: 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	Other: 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	Other: 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	Other: 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.

Outcome Measures

Primary Outcome Measures :

Correlating the arithmetic markers (CORR and MAD) to the distance between the pacing site and origin of the ventricular tachycardia or the index pacing site. [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients will be recruited from consecutive patients referred for ablation of sustained ventricular tachycardia with or without structural heart disease or Patients referred for ablation of supraventricular tachycardia to the QEII Health Sciences Centre, in Halifax, NS.

Criteria

Inclusion Criteria:

All patients presenting with sustained monomorphic VT who are amenable to VT ablation.
Patients referred for ablation of supraventricular tachycardia.

Exclusion Criteria:

Patients presenting with ventricular tachycardia if no sustained tachycardia can be induced, or if in that particular patient pace-mapping is known to be an inaccurate method of mapping (e.g. in bundle branch reentry VT or fascicular VT).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170416

Locations


Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7

Sponsors and Collaborators

John Sapp

Investigators


Principal Investigator:	John A Sapp, MD, FRCPC	Nova Scotia Health Authority

More Information

Publications:

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, Jaïs 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.

Stevenson WG, Soejima K. Catheter ablation for ventricular tachycardia. Circulation. 2007 May 29;115(21):2750-60. Review.

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.

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. Epub 2006 Nov 27.

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; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. 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 Sep 5;114(10):e385-484. Epub 2006 Aug 25.

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.


Responsible Party:	John Sapp, Electrophysiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:	NCT01170416 History of Changes
Other Study ID Numbers:	SP12
First Posted:	July 27, 2010 Key Record Dates
Last Update Posted:	May 17, 2016
Last Verified:	May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by John Sapp, Nova Scotia Health Authority:


Ventricular Tachycardia Body Surface Mapping

Additional relevant MeSH terms:


Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac	Heart Diseases Cardiovascular Diseases Pathologic Processes

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