Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)

CardioFocus

Status and phase: Terminated; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Standard Anti-arrhythmic Drug (AAD) Therapy; Device: Endoscopic Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00477230

ENABLE 25-2064

Details and patient eligibility

About

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:

• A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
• Standard drug therapy (antiarrhythmic drugs)

To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.

Eligibility Criteria

Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:

• 18 to 80 years of age
• Frequent episodes of AF
• Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
• Other criteria

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 80 years old
• Paroxysmal atrial fibrillation (AF)
• Frequent episodes of AF
• Failed at least 1 drug treatment
• Others

Exclusion criteria

• Others

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

1

Experimental group

Description:

Single ablation procedure with Endoscopic Ablation System

Treatment:

Device: Endoscopic Ablation System

2

Active Comparator group

Description:

Medication

Treatment:

Drug: Standard Anti-arrhythmic Drug (AAD) Therapy