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

Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03470636

Enrollment

Registered

2018-03-20

Start date

2018-02-15

Completion date

2020-01-16

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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.

Interventions

DEVICEHeartLight X3

Pulmonary vein isolation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* paroxysmal atrial fibrillation failure of at least one AAD others

Exclusion criteria

* overall good health as established by multiple criteria

Design outcomes

Primary

Measure	Time frame	Description
Ablation time	Acute - at the end of the index procedure	Ablation time

Secondary

Measure	Time frame	Description
Procedure time	Acute - at the end of the index procedure	Procedure time
PV Isolation	Acute - at the end of the index procedure	Percent of isolated pulmonary veins
PAE Rate	30 Days	Primary Adverse Event rate
AF Free Rate	6 and 12 months	6- and 12-month chronic results

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026