Testing Objective Methods for Template Matching Ventricular Tachycardia and Pacemapping

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Sapp, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01170416
First received: July 25, 2010
Last updated: May 13, 2016
Last verified: May 2016
  Purpose
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 Intervention
Ventricular Tachycardia
Other: 12-lead body surface mapping

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Measurements Comparing Body Surface Potentials During Pacemapping and Spontaneous Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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. 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.
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.

Responsible Party: John Sapp, Electrophysiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01170416     History of Changes
Other Study ID Numbers: SP12 
Study First Received: July 25, 2010
Last Updated: May 13, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Nova Scotia Health Authority:
Ventricular Tachycardia
Body Surface Mapping

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 25, 2016