Physiologically Guided VT Ablation

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04004624
• Other study ID #: PhysioVT1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2019
• Source: Center for Cardiovascular Reseach and Innovation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 1, 2020
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Ablation
Cardiac Ablation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Center for Cardiovascular Reseach and Innovation	Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of VT recurrence or death		36 months follow-up