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Peri-Procedural Transmural Electrophysiological (EP) Imaging of Scar-Related Ventricular Tachycardia (ECGI-VT)

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ClinicalTrials.gov Identifier: NCT03713866
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Nova Scotia Health Authority
Rochester Institute of Technology
Information provided by (Responsible Party):
John Sapp, Nova Scotia Health Authority

Brief Summary:

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. An important treatment is to use catheter ablation to "block" the channel that forms the circuit. Effective ablation requires imaging guidance to visualize the VT circuit relative to scar structures in 3D. Unfortunately, with conventional catheter mapping, up to 90% of the VT circuits are too short-lived to be mapped. For the 10% "mappable" VTs, their data are only available during ablation and limited to one ventricular surface. This inadequacy of functional VT data largely limits the knowledge about scar-related VT and ablation strategies, and reduces the ability of clinicians to identify ablation targets and assess ablation outcome.

The central hypothesis of this proposal is that functional VT data, integrated with CT or MRI scar data in 3D, can improve VT ablation efficacy with pre-procedural identification of ablation targets and post-procedural mechanistic elucidation of ablation failure. This research builds on the rapidly increasing clinical interest in electrocardiographic imaging (ECGi), an emerging technique that obtains cardiac electrical activity through inverse reconstructions from ECGs. The specific objective is to push the boundary of ECGi to provide - as a conjunction to intra-procedural catheter mapping - pre-ablation and post-ablation imaging of functional VT circuits integrated with 3D scar structure.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Myocardial Infarction Diagnostic Test: EP Imaging and Testing Not Applicable

Detailed Description:

Electrocardiographic imaging (ECGi) is an emerging technique to image cardiac electrical activity through inverse reconstructions from body-surface ECGs. After 40 years of active research, the potential of ECGi as a noninvasive adjunct to catheter mapping is gaining rapid attention in the clinical community.

A total of 40 consecutive post-infarction VT patients will be prospectively enrolled and recruited from those who have been referred for catheter ablation of scar-related VT. Within 7 days before the ablation procedure, these patients will undergo noninvasive cardiac CT or MRI imaging and noninvasive programmed stimulation (NIPS) study with simultaneous 120-lead body- surface ECG mapping (pre-ablation NIPS). MRI will be performed for patients with implantable defibrillators for whom it is considered safe to do so. CT imaging will be performed for those with Implantable Cardioverter Defibrillators (ICDs) which are not MRI compatible.

At the time of scheduled ablation, all patients will undergo standard catheter mapping and ablation procedure as a part of standard care. Within 7 days after the ablation procedure, the patients will undergo cardiac MRI imaging and noninvasive programmed stimulation (NIPS) with simultaneous 120-lead body-surface ECG mapping (post-ablation NIPS). For patients who cannot undergo MRI, CT imaging will not be repeated.

At 6 months after the procedure, a follow-up will occur as a part of standard care where outcome data regarding the chronic success of the ablation procedure will be collected and ICD interrogation will be performed. No imaging or mapping is planned at the follow-up.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Peri-Procedural Transmural Electrophysiological Imaging of Scar-Related Ventricular Tachycardia
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EP Imaging and Testing
MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.
Diagnostic Test: EP Imaging and Testing

Magnetic Resonance Imaging: pre-procedure imaging is standard care prior to catheter ablation procedures for VT to document anatomy of the heart.

120-Lead Body Surface Mapping: a 120-lead ECG will be recorded using a standardized mapping protocol. 120 disposable radiolucent silver chloride (Ag/AgCl) surface electrodes will be placed on the torso in 18 strips and connected via cables to an advanced acquisition system.

Noninvasive programmed stimulation (NIPS) study will be performed using the patient's implanted defibrillator, and is part of standard practice during a VT catheter ablation.





Primary Outcome Measures :
  1. Termination of Ventricular Tachycardia [ Time Frame: Less than 10 minutes post ablation ]
    The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.

  2. VT recurrence rate [ Time Frame: Less than 6 months post procedure ]
    Any recurring VT occurring within 6 months post procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One or more episodes of sustained monomorphic VT
  • Referred for catheter ablation
  • Previously implanted ICD
  • Signed the patient informed consent form
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

  • Have estimated Glomerular Filtration Ratio (eGFR) less than 30
  • Have a life expectancy less than 6 months or are listed for heart transplantation at time of inclusion
  • Are pregnant
  • Are on IV inotropic agents
  • Have any contraindication to catheter ablation (including but not limited to mechanical prosthetic aortic and mitral valves, known protruding Left Ventricular (LV) thrombus
  • New York Heart Association (NYHA) functional class IV
  • Had ST wave elevation myocardial infarction within < 1 month
  • Unwilling or unable to undergo cardiac MRI scan AND unwilling or unable to undergo cardiac CT scan (e.g. contrast allergy).

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): NCT03713866


Contacts
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Contact: John L Sapp, MD FRCPC 902 473 4272 john.sapp@nshealth.ca
Contact: Karen A Giddens 902 473 2758 karen.giddens@nshealth.ca

Sponsors and Collaborators
John Sapp
Nova Scotia Health Authority
Rochester Institute of Technology
Investigators
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Principal Investigator: John L Sapp, MD FRCPC Nova Scotia Health Authority

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Responsible Party: John Sapp, Staff Cardiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03713866     History of Changes
Other Study ID Numbers: SAPP006
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease