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

Primary Purpose

Ventricular Tachycardia, Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EP Imaging and Testing
Sponsored by
John Sapp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • QEII HSCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EP Imaging and Testing

Arm Description

MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.

Outcomes

Primary Outcome Measures

Termination of Ventricular Tachycardia
The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.
VT recurrence rate
Any recurring VT occurring within 6 months post procedure

Secondary Outcome Measures

Full Information

First Posted
October 17, 2018
Last Updated
February 13, 2023
Sponsor
John Sapp
Collaborators
Nova Scotia Health Authority, Rochester Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03713866
Brief Title
Peri-Procedural Transmural Electrophysiological (EP) Imaging of Scar-Related Ventricular Tachycardia
Acronym
ECGI-VT
Official Title
Peri-Procedural Transmural Electrophysiological Imaging of Scar-Related Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Sapp
Collaborators
Nova Scotia Health Authority, Rochester Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EP Imaging and Testing
Arm Type
Experimental
Arm Description
MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.
Intervention Type
Diagnostic Test
Intervention Name(s)
EP Imaging and Testing
Intervention Description
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 Measure Information:
Title
Termination of Ventricular Tachycardia
Description
The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.
Time Frame
Less than 10 minutes post ablation
Title
VT recurrence rate
Description
Any recurring VT occurring within 6 months post procedure
Time Frame
Less than 6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John L Sapp, MD FRCPC
Phone
902 473 4272
Email
john.sapp@nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karen A Giddens
Phone
902 473 2758
Email
karen.giddens@nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Sapp, MD FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII HSC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen A Giddens
Phone
9024732758
Email
karen.giddens@nshealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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