Physiologically Guided VT Ablation

Not Applicable

• Conditions: Ventricular Tachycardia
• Interventions: Device: Ablation

• Registration Number: NCT04004624
• Lead Sponsor: Center for Cardiovascular Reseach and Innovation

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

Study Timeline

• Study Start: 2014-10-12
• Status Verified: 2019-06
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-06-28
• Last Update Submitted: 2019-06-28
• Study First Posted: 2019-07-02
• Last Update Posted: 2019-07-02
• Primary Completion: 2019-09-16
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	Ablation	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.

Primary Outcome Measures

Name	Time	Method
Composite of VT recurrence or death	36 months follow-up