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Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

NCT03204981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-10-12

Study results available
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Summary

This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.

Conditions

  • Ventricular Arrythmia

Interventions

DEVICE

Intramural Needle Ablation

The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.

PROCEDURE

Ablation

standard ablation

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2021-04-20
Completion
2021-04-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204981 on ClinicalTrials.gov