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

CardioFocus60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

HeartLight X3DEVICE

Pulmonary vein isolation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * paroxysmal atrial fibrillation failure of at least one AAD others Exclusion Criteria: * overall good health as established by multiple criteria

Locations (1)

Nemocnice Na Homolce

Prague, Czechia

Outcomes

Primary Outcomes

Ablation time

Time frame: Acute - at the end of the index procedure

Secondary Outcomes

Procedure time

Time frame: Acute - at the end of the index procedure

PV Isolation

Percent of isolated pulmonary veins

Time frame: Acute - at the end of the index procedure

PAE Rate

Primary Adverse Event rate

Time frame: 30 Days

AF Free Rate

6- and 12-month chronic results

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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