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Procedure
Electrophysiological Imaging for Ventricular Tachycardia (ECGI-VT Trial)
N/A
Recruiting
Led By John L Sapp, MD FRCPC
Research Sponsored by John Sapp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
One or more episodes of sustained monomorphic VT
Be older than 18 years old
Must not have
Are on IV inotropic agents
Had ST wave elevation myocardial infarction within < 1 month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less than 6 months post procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to map and treat ventricular tachycardia, which contributes to over 350,000 sudden deaths each year in the US. The new method uses catheter ablation to "block" the channel that forms the circuit, with guidance from 3D images. The hope is that this will improve ablation efficacy and help clinicians identify ablation targets and assess ablation outcome.
Who is the study for?
This trial is for individuals who have had a heart attack or suffer from rapid, irregular heartbeats known as ventricular tachycardia and are scheduled for catheter ablation. Participants must have experienced sustained VT episodes, have an implantable cardioverter-defibrillator (ICD), and be able to follow the study's procedures. People with severe kidney issues, short life expectancy, listed for heart transplant, pregnant women, those on certain heart medications or with conditions that prevent MRI or CT scans cannot join.
What is being tested?
The trial is testing EP Imaging and Testing to improve treatment of ventricular tachycardia by using advanced imaging techniques combined with standard care. The goal is to better identify where in the heart's tissue electrical 'short circuits' occur before and after procedures like catheter ablation.
What are the potential side effects?
While specific side effects are not detailed here, typical risks may include discomfort at the imaging site, potential allergic reactions to contrast materials used in CT/MRI scans if applicable, and general risks associated with catheter ablation such as bleeding or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one or more episodes of a specific type of irregular heartbeat.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am receiving medication through an IV to strengthen my heart muscle.
Select...
I had a severe heart attack less than a month ago.
Select...
My doctor expects I have less than 6 months to live or I am on the heart transplant list.
Select...
I cannot or will not have a heart MRI or CT scan.
Select...
I cannot undergo catheter ablation due to certain health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less than 6 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than 6 months post procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Termination of Ventricular Tachycardia
VT recurrence rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EP Imaging and TestingExperimental Treatment1 Intervention
MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.
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Who is running the clinical trial?
John SappLead Sponsor
5 Previous Clinical Trials
712 Total Patients Enrolled
Nova Scotia Health AuthorityOTHER
288 Previous Clinical Trials
94,542 Total Patients Enrolled
Rochester Institute of TechnologyOTHER
11 Previous Clinical Trials
4,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe heart problems that limit your ability to do everyday activities.Your kidney function, measured by eGFR, is very low (less than 30).I am receiving medication through an IV to strengthen my heart muscle.I had a severe heart attack less than a month ago.My doctor expects I have less than 6 months to live or I am on the heart transplant list.I cannot or will not have a heart MRI or CT scan.I cannot undergo catheter ablation due to certain health issues.You have had a defibrillator implanted before.I am referred for a procedure to treat heart rhythm problems.I have had one or more episodes of a specific type of irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: EP Imaging and Testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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