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Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia (EZCF-125)

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Biosense Webster

Status and phase

Completed
Phase 2
Phase 1

Conditions

Atrial Fibrillation
Ischemic Ventricular Tachycardia

Treatments

Device: Radiofrequency Catheter Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01032317
EZCF-125

Details and patient eligibility

About

The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion criteria

  • Longstanding persistent AF
  • Idiopathic VT
  • Congestive Heart Failure

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Single-arm Study
Other group
Description:
This study was completed prior to the implementation of the requirement for specific identification of study arms. As the requirement was not made retroactive to completed studies, we believe this study to be exempt from the stipulation. Also, per PRS definition, since this is for a single-arm/feasibility study, the data elements are optional.
Treatment:
Device: Radiofrequency Catheter Ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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