Physiologically Guided VT Ablation

NCT04004624 | Unknown DMC FDA Device

• 1 other identifier: PhysioVT1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Composite of VT recurrence or death

  36 months follow-up

Study Arms (2)

Study Arm

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Ablation DEVICE

Cardiac Ablation

Study Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Center for Cardiovascular Reseach and Innovation: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: October 12, 2014
• Primary Completion: September 16, 2019
• Study Completion: January 1, 2020
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share