Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon

CardioFocus

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: HeartLight X3

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470636

25-4378

Details and patient eligibility

About

The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

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60 participants in 1 patient group

HeartLight X3

Experimental group

Description:

Pulmonary vein isolation using HeartLight X3

Treatment:

Device: HeartLight X3