Physiologically Guided VT Ablation
Primary Purpose
Ventricular Tachycardia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
- Planned for first VT ablation procedure.
- Patients must have an ICD or a plan for ICD implantation after the ablation.
- Ability to understand the requirement of the study and to sign an informed consent.
Exclusion Criteria:
- Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
- The VT substrate is thought not to be related to coronary disease.
- Presence of ongoing ischemia that is thought to be the cause of the VT.
- Contraindication to anticoagulation therapy
- Stroke within 30 days before enrollment.
- Life expectancy <1 year for any medical condition.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study Arm
Control
Arm Description
The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
Outcomes
Primary Outcome Measures
Composite of VT recurrence or death
Secondary Outcome Measures
Full Information
NCT ID
NCT04004624
First Posted
June 28, 2019
Last Updated
June 28, 2019
Sponsor
Center for Cardiovascular Reseach and Innovation
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04004624
Brief Title
Physiologically Guided VT Ablation
Official Title
Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2014 (Actual)
Primary Completion Date
September 16, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Cardiovascular Reseach and Innovation
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
Detailed Description
Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.
Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.
The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.
The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Active Comparator
Arm Description
The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
Intervention Type
Device
Intervention Name(s)
Ablation
Intervention Description
Cardiac Ablation
Primary Outcome Measure Information:
Title
Composite of VT recurrence or death
Time Frame
36 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
Planned for first VT ablation procedure.
Patients must have an ICD or a plan for ICD implantation after the ablation.
Ability to understand the requirement of the study and to sign an informed consent.
Exclusion Criteria:
Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
The VT substrate is thought not to be related to coronary disease.
Presence of ongoing ischemia that is thought to be the cause of the VT.
Contraindication to anticoagulation therapy
Stroke within 30 days before enrollment.
Life expectancy <1 year for any medical condition.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiologically Guided VT Ablation
We'll reach out to this number within 24 hrs