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Clinical Trials/ISRCTN93591221
ISRCTN93591221
Completed
未知

Prospective early feasibility study utilizing a novel mapping catheter for mapping in the atria and ventricles

Biosense Webster, Inc.0 sites30 target enrollmentAugust 2, 2018
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ConditionsVentricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillationCirculatory System

Overview

Phase
未知
Intervention
Not specified
Conditions
Ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation
Sponsor
Biosense Webster, Inc.
Enrollment
30
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 2, 2018
End Date
February 8, 2019
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosed with and is a candidate for clinically\-indicated catheter ablation procedure for the management of:
  • •1\.1\. Ischemic ventricular tachycardia
  • •1\.2\. Atrial tachycardia/atypical atrial flutter/paroxysmal atrial fibrillation following a pulmonary vein isolation ablation or mitral valve repair procedure
  • •1\.3\. Persistent atrial fibrillation
  • •2\. Aged 18 years or older
  • •3\. Able to provide informed consent
  • •4\. Able and willing to comply with all pre\-, post\-, and follow\-up testing and requirements

Exclusion Criteria

  • •1\. History of continuous atrial fibrillation (AF) sustained longer than 12 months
  • •2\. History of AF \<7 days and no previous AF ablation procedure
  • •3\. Previously diagnosed with long\-standing persistent atrial fibrillation
  • •4\. Previously diagnosed with idiopathic PVC/VT
  • •5\. Study arrhythmia secondary to reversible cause
  • •6\. Atrial arrhythmias: patients with a left atrial size \>55 mm
  • •7\. LVEF \= 25% for VT patients
  • •8\. LVEF \= 40% for AF patients
  • •9\. Documented thrombus in the chamber to be mapped by the study catheter on imaging
  • •10\. Contraindication to anticoagulation (i.e. heparin, warfarin, dabigatran)

Outcomes

Primary Outcomes

Not specified

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