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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04004624
Other study ID # PhysioVT1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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