Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

C

CardioFocus

Status and phase

Completed
Phase 2

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: CardioFocus HeartLight Endoscopic Ablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971204
25-2734

Details and patient eligibility

About

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 to 70 years
  • paroxysmal atrial fibrillation
  • failure of at least one AAD
  • others

Exclusion criteria

overall good health as established by multiple criteria

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Treatment with HeartLight System
Experimental group
Description:
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Treatment:
Device: CardioFocus HeartLight Endoscopic Ablation System

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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