Physiologically Guided VT Ablation

NCT ID: NCT04004624

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-12
• Study Completion Date: 2020-01-01

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

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ablation

Intervention Type: DEVICE

Cardiac Ablation

Control

Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ablation

Cardiac Ablation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Center for Cardiovascular Reseach and Innovation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PhysioVT1

Identifier Type: -

Identifier Source: org_study_id