Physiologically Guided VT Ablation

Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia

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.

Study Overview

• Status: Unknown
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Ablation

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years
2. History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
3. Planned for first VT ablation procedure.
4. Patients must have an ICD or a plan for ICD implantation after the ablation.
5. Ability to understand the requirement of the study and to sign an informed consent.

Exclusion Criteria:

1. Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
2. The VT substrate is thought not to be related to coronary disease.
3. Presence of ongoing ischemia that is thought to be the cause of the VT.
4. Contraindication to anticoagulation therapy
5. Stroke within 30 days before enrollment.
6. Life expectancy <1 year for any medical condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Arm; 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.	Device: Ablation; Cardiac Ablation
No Intervention: Control; Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of VT recurrence or death	36 months follow-up

Collaborators and Investigators

• Sponsor: Center for Cardiovascular Reseach and Innovation
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2014
• Primary Completion (Anticipated): September 16, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: PhysioVT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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